Device recall: Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial…
Class II FDA enforcement event 77232. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
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 9 May 2017. The firm address in the FDA record is in Reading, PA. FDA put the recall in Class II. FDA event 77232 has 12 product records. The first FDA enforcement report date is 21 Jun 2017. The record gives the status Terminated, with the termination date 17 Sep 2018.
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.
Worldwide Distribution - US (nationwide) and Canada
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
12 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2327-2017 | Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels | 27, 485 distributed in the U.S, 4,371 distributed Internationally | Class II | Terminated | 21 Jun 2017 |
| Z-2328-2017 | Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation | 27,485 units distributed in U.S., 4,371 units distributed internationally | Class II | Terminated | 21 Jun 2017 |
| Z-2329-2017 | 1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit | 27,485 units distributed in U.S, 4,371 units distributed internationally | Class II | Terminated | 21 Jun 2017 |
| Z-2330-2017 | 1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features 3)Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue Plus (R)… | 27,485 units distributed in U.S., 4,371 units distributed internationally | Class II | Terminated | 21 Jun 2017 |
| Z-2331-2017 | 1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The 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… | 27,485 units distributed in U.S., 4,371 units distributed internationally | Class II | Terminated | 21 Jun 2017 |
| Z-2332-2017 | Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is… | 27,485 units distributed in U.S., 4,371 units distributed internationally | Class II | Terminated | 21 Jun 2017 |
| Z-2333-2017 | 1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 4) ARROWg+ard Blue PSI Kit The MACTM two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation.… | 27,485 untis distributed in U.S., 4,371 units distributed internationally | Class II | Terminated | 21 Jun 2017 |
| Z-2334-2017 | 1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be inserted into the jugular,… | 27,485 units distributed in the U.S., 4,371 units distributed internationally | Class II | Terminated | 21 Jun 2017 |
| Z-2335-2017 | Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation | 27,485 units distributed in U.S., 4,371 units distributed internationally | Class II | Terminated | 21 Jun 2017 |
| Z-2336-2017 | Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation. | 27,485 units distributed in U.S., 4,371 units distributed internationally | Class II | Terminated | 21 Jun 2017 |
| Z-2337-2017 | ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation | 27,485 units distributed in U.S., 4,371 units distributed internationally | Class II | Terminated | 21 Jun 2017 |
| Z-2338-2017 | Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling. | 27,485 units distributed in U.S., 4,371 units distributed internationally | Class II | Terminated | 21 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
- 12Median of the firm: 1
- Events of the firm on the register
- 93
Other events of the firm
Official channels
- FDA enforcement report Z-2327-2017The 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.
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Cite this page
Recall Register. FDA enforcement event 77232. https://recallregister.com/fda/ii/77232/. 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:
Worldwide Distribution - US (nationwide) and Canada
- What quantity of product is in FDA event 77232?
- The event has 12 product records. The first record gives this quantity:
27, 485 distributed in the U.S, 4,371 distributed Internationally
- 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.