FDA Device recall Z-2330-2017
1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit…
- FDA Device
- Class II
- terminated
- Published 2017-06-21
On 2017-06-21 the FDA classified a Class II recall of 1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit… by Arrow International, citing arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2330-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-09 |
| Published | 2017-06-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Arrow International |
| Distribution | US |
Product
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) Catheter and Sharps Safety Features 4) Multi-Lumen Pressure Injectable Central Venous Catheterization Kit with Blue Flex Tip(R)ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features 5)Pressure Injectable ARROWg+ard Blue Plus (R) Multi-Lumen Central Venous Catheterization Kit 6)AGB+Multi-Lumen Central Venous Catheterization Kit 7) AGB+Pressure Injectable Multi-Lumen CVC Kit The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access. Catheter, Intravascular, Therapeutic, Short Term Less Than 30 days
Reason
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Identifiers
| code_info | Material number: ASK-12703-PLV1, ASK-15703-PLV, ASK-15703-PRH, ASK-42703-PRJ, ASK-45703-PRH, ASK-45703-PRWJ1, AK-4270…Material number: ASK-12703-PLV1, ASK-15703-PLV, ASK-15703-PRH, ASK-42703-PRJ, ASK-45703-PRH, ASK-45703-PRWJ1, AK-42703-P1A, AK-45703-P1A, CA-42703-P1A, CA-45703-P1A, CDA-42703-P1A, CDA-42802-P1A, CDA-45703-P1A, Device Listing D040746 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2330-2017%22
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