Device recall: Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires; Product Code: AI-07000
Class II FDA enforcement event 79890. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Product sterility may be compromised due to unsealed packaging.
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 11 Apr 2018. The firm address in the FDA record is in Reading, PA. FDA put the recall in Class II. FDA event 79890 has 76 product records. The first FDA enforcement report date is 6 Jun 2018. The record gives the status Terminated, with the termination date 15 May 2020.
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 . openFDA export of .
Distribution
In the words of FDA.
US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA,…
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
76 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1957-2018 | Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires; Product Code: AI-07000 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1958-2018 | Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18080-N, AB-18110-N | 416, 055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1959-2018 | Echogenic Introducer Needle; Product Code: AN-04318 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1960-2018 | Spring Wire Guide Introducer Needle; Product Codes: AN-04320 and AN-04418 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1961-2018 | Epidural Needle; Product Codes: AN-05501 and AN-05505 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1962-2018 | SnapLock" Catheter/Syringe Adapter; Product Code: AS-05500 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1963-2018 | Maximal Barrier Drape; Product Codes: ASK-00001-1A | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1964-2018 | Maximal Barrier Drape; Product Codes: ASK-00002-1A | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1965-2018 | Maximal Barrier Drape; Product Codes: ASK-00376-SU | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1966-2018 | Maximal Barrier Drape; Product Code: ASK-01000-UPMS | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1967-2018 | Maximal Barrier Drape; Product Code: ASK-04000-HMC | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1968-2018 | Radial Arterial Access Kit; Product Code: ASK-04001-BID2 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1969-2018 | Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1970-2018 | Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1971-2018 | Arterial Catheterization Kit; Product Codes: ASK-04020-DH | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1972-2018 | Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1973-2018 | Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1974-2018 | Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Codes: ASK-04301-TJ | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1975-2018 | Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters ; Product Codes: ASK-09903-UM | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1976-2018 | Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-09903-UPA | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1977-2018 | Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Features (Recommended for use with 7 Fr. Catheters); Product Code: ASK-09907-SB | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1978-2018 | Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1979-2018 | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-15703-LDP1 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1980-2018 | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1981-2018 | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PVH and ASK-15703-PNYP | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1982-2018 | ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr. Catheters; Product Code: ASK-21142-WHC2 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1983-2018 | MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-21242-NYP and ASK-21242-PR | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1984-2018 | Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter and Sharps Safety Features; Product Code: ASK-24306-VC | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1985-2018 | ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and ASK-24306-WHC2 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1986-2018 | 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; Product Codes: ASK-29803-SJH, ASK-29903-SJH, and ASK-29903-UW1 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1987-2018 | Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-MHW and ASK-42703-OLL1 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1988-2018 | Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703-PNY, ASK-45703-PWHC1 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1989-2018 | ARROWg+ard Blue PLUS Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1990-2018 | Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Code: ASK-45802-PHMW | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1991-2018 | Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-45854-PSFM and ASK-42854-PRR | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1992-2018 | ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit; Product Code: CDC-42802-P1A | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1993-2018 | Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit; Product Code: ASK-42802-PWHC1 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1994-2018 | ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703-P1A | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1995-2018 | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Codes: ASK-45703-LDP1, ASK-45703-PBHS, ASK-45703-PHMC | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1996-2018 | 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; Product Code: ASK-42703-PHCH | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1997-2018 | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-PTJH and ASK-45703-PTJH | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1998-2018 | Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-RV1 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-1999-2018 | Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-RV1 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-2000-2018 | ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-2001-2018 | Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42802-VC and ASK-47702-VC | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-2002-2018 | Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42802-DMC | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-2003-2018 | Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product code: ASK-45703-AEH | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-2004-2018 | Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions; Product Codes: ASK-45703-SCH; ASK-45703-UAB, ASK-45703-VAH | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-2005-2018 | ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: ASK-45703-VC | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-2006-2018 | 4Fr. Catheter Clamp with Fastener; Product Code: CC-00004 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-2007-2018 | 5Fr. Catheter Clamp with Fastener; Product Code: CC-00005 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-2008-2018 | 7Fr. Catheter Clamp with Fastener; Product Code: CC-00007 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-2009-2018 | 8Fr. Catheter Clamp with Fastener; Product Code: CC-00008 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-2010-2018 | Clear Fenestrated Drape with Adhesive; Product Code: CD-00001 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-2011-2018 | Spring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-2012-2018 | TheraCath(R) Epidural Catheter; Product Code: EC-05000 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-2013-2018 | 0.2 Micron Flat Epidural Filter; Product Code: EF-05500 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-2014-2018 | Arrow-Johans" ECG Adapter for Right Atrial Electrocadiography (RAECG); Product Code: EG-04900 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-2015-2018 | ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-42563-HPHNM | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
| Z-2016-2018 | 10 cc Luer-Slip Loss of Resistance Syringe; Product Code: LR-05501 | 416,055 total products | Class II | Terminated | 6 Jun 2018 |
The table shows 60 of 76 product records. The FDA enforcement report lists all the records.
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 2018
- 1,074
- Share of these events in Class II
- 92%
- Product records in this event
- 76Median of the firm: 1
- Events of the firm on the register
- 93
Other events of the firm
Official channels
- FDA enforcement report Z-1957-2018The 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 79890. https://recallregister.com/fda/ii/79890/. Source: openFDA enforcement reports. Data through .
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:
US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA,…
- What quantity of product is in FDA event 79890?
- The event has 76 product records. The first record gives this quantity:
416,055 total products
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 92% of the 1,074 device events that started in 2018 are in Class II.