Device recall: MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve, Sharps…

Class II FDA enforcement event 76937. Recall start date: 20 Mar 2017. Status in the FDA record: Terminated. Termination date: 18 Dec 2018.

Reason for recall, in the words of FDA

Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Arrow International Inc started this device recall on 20 Mar 2017. The firm address in the FDA record is in Reading, PA. FDA put the recall in Class II. FDA event 76937 has 56 product records. The first FDA enforcement report date is 14 Jun 2017. The record gives the status Terminated, with the termination date 18 Dec 2018.

FDA enforcement report The 56 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide Distribution

Recalling firm

Arrow International Inc, Reading, PA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

56 product records in the event.

FDA event 76937: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2253-2017	MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter…	unknown-firm reports total devices distributed 43,394 eaches	Class II	Terminated	14 Jun 2017
Z-2254-2017	ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins.…	unknown-firm reports total devices distributed 43,394 eaches	Class II	Terminated	14 Jun 2017
Z-2255-2017	ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended…	unknown-firm reports total devices distributed 43,394 eaches	Class II	Terminated	14 Jun 2017
Z-2256-2017	Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling	unknown-firm reports total devices distributed 43,394 eaches	Class II	Terminated	14 Jun 2017
Z-2257-2017	Arrow VPS Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally inserted Central Venous Catheter The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple…	43,394 units	Class II	Terminated	14 Jun 2017
Z-2258-2017	Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids,…	43,394 units	Class II	Terminated	14 Jun 2017
Z-2259-2017	MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 -8 Fr. Catheters. The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter…	43,394 units	Class II	Terminated	14 Jun 2017
Z-2260-2017	Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions. The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central…	43,394 units	Class II	Terminated	14 Jun 2017
Z-2261-2017	Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostatis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5-8 Fr. Catheters. The Arrow Percutaneous Sheath Introducer permits venous access and catheter introduction to the central circulation. The…	43,394 units	Class II	Terminated	14 Jun 2017
Z-2262-2017	Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure injectable P1CC with chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion,…	43,394 units	Class II	Terminated	14 Jun 2017
Z-2263-2017	ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit. The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy,…	43,394 units	Class II	Terminated	14 Jun 2017
Z-2264-2017	ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The MAC Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation	43,394 units	Class II	Terminated	14 Jun 2017
Z-2265-2017	ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration	43,394 units	Class II	Terminated	14 Jun 2017
Z-2266-2017	Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the central circulation through a peripheral vein	43,394 units	Class II	Terminated	14 Jun 2017
Z-2267-2017	Pressure injectable Jugular Axillo-Subclavian Central CThe CG+Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central veinatheter (JACC) Product	43,394 units	Class II	Terminated	14 Jun 2017
Z-2268-2017	Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.	43,394 units	Class II	Terminated	14 Jun 2017
Z-2269-2017	Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling	43,394 units	Class II	Terminated	14 Jun 2017
Z-2270-2017	ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit. The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It ma be inserted into the jugular, subclavian or femoral veins	N/A	Class II	Terminated	14 Jun 2017
Z-2271-2017	Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited to the following: multiple…	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2272-2017	Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access…	N/A	Class II	Terminated	14 Jun 2017
Z-2273-2017	Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring…	N/A	Class II	Terminated	14 Jun 2017
Z-2274-2017	Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited to the following: multiple infusions of…	N/A	Class II	Terminated	14 Jun 2017
Z-2275-2017	Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access including, but not limited to the…	N/A	Class II	Terminated	14 Jun 2017
Z-2276-2017	Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring…	unknown-firm reports total devices distributed 43,394 each	Class II	Terminated	14 Jun 2017
Z-2277-2017	Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous access…	N/A	Class II	Terminated	14 Jun 2017
Z-2278-2017	AGB+ Pressure Injectable Multi-Lumen CVC Kit intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins	N/A	Class II	Terminated	14 Jun 2017
Z-2279-2017	AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.The ARROWg+ard Blue Catheter permits venous access to the central circulation by way of the femoral, jugular, or…	N/A	Class II	Terminated	14 Jun 2017
Z-2280-2017	Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.	N/A	Class II	Terminated	14 Jun 2017
Z-2281-2017	Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the…	N/A	Class II	Terminated	14 Jun 2017
Z-2282-2017	Arrow VPS Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the…	N/A	Class II	Terminated	14 Jun 2017
Z-2283-2017	Arrow VPS Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the…	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2284-2017	Arrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the…	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2285-2017	Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure Injectable P1CC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion,…	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2286-2017	Arrow PICC with Chlorag+ard Technology The ArrowEVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast…	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2287-2017	Arrow Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature.	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2288-2017	Arrow(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature.	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2289-2017	Arrow Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The Arrow GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2290-2017	Arrow Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The Arrow GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2291-2017	Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the central circulation through a peripheral vein. The intended use of the VP'S Stylet and Console (VPS System) is to quickly and accurately guide market available central catheters to the desired location which is the lower third of the SVC or at…	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2292-2017	"Pressure Injectable Jugular Axillo-Subclavian Central Catheter (JACC) Product" The CG+ Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central vein. The VPS Stylet, used with the VPS Console, quickly and accurately guides the central catheters to the desired location…	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2293-2017	Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7 - 7.5¿¿Fr. Catheters The Arrow Percutaneous Sheath Introducer permits venous access and catheter introduction to the central ciruclation	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2294-2017	Femoral Arterial Line Catheterization Kit The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2295-2017	Femoral Arterial Line Catheterization Kit The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2296-2017	Radial Artery Catheterization Kit with Sharps Safety Features The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2297-2017	Radial Artery Catheterization Kit with Sharps Safety Features The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2298-2017	QuickFlash Radial Artery/Arterial Line Catheterization Kit The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2299-2017	Arterial Catheterization Kit with Maximal Barrier Precautions The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2300-2017	Arterial Catheterization Kit The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2301-2017	QuickFlash(R) Radial Artery/Arterial Line Catheterization Kit The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2302-2017	Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2303-2017	ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2304-2017	Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5-8 Fr. Catheters The Arrow Percutaneous Sheath Introducer permits venous access and catheter introduction to the central circulation. The…	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2305-2017	ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy;…	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2306-2017	Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring…	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2307-2017	ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids,…	unknown-firm reports total devices distributed 43,394	Class II	Terminated	14 Jun 2017
Z-2308-2017	ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids,…	N/A	Class II	Terminated	14 Jun 2017

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2017: 1,091
Share of these events in Class II: 93%
Product records in this event: 56Median of the firm: 1
Events of the firm on the register: 93

Other events of the firm

Other FDA enforcement events of Arrow International Inc
Initiated	Product (first record)	Type	Class	Records
26 Jul 2024	Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Inc	Device	Class II	1
29 Apr 2024	Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS	Device	Class I	3
12 Feb 2024	ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FM	Device	Class I	1
10 Aug 2023	Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, R	Device	Class I	4
10 Aug 2023	Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular	Device	Class II	2
19 May 2023	ARROW Endurance Extended Dwell Peripheral Catheter System	Device	Class I	1
27 Oct 2022	Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer	Device	Class I	2
17 Oct 2022	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump	Device	Class I	31
14 Sep 2022	ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JH	Device	Class II	1
5 May 2022	Arrow Three-Lumen CVC	Device	Class II	1

Arrow International Inc: all 93 events

Official channels

FDA enforcement report Z-2253-2017The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 76937. https://recallregister.com/fda/ii/76937/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide Distribution
What quantity of product is in FDA event 76937?: The event has 56 product records. The first record gives this quantity: unknown-firm reports total devices distributed 43,394 eaches
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2017 have the same class?: 93% of the 1,091 device events that started in 2017 are in Class II.