Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dres
FDA device recall Z-1030-2015 · posted 2015-01-29 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.
- Action taken
- Arrow International, Inc. (Arrow) sent notification letters, dated January 9, 2015, to alert their direct account customers that it may be necessary to obtain an alternate Biopatch Dressing if a kit is used that contains an incorrectly sized Biopatch Dressing. Due to the inconvenience, Arrow will reimburse customers $7.50 per kit received.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- OBJ
- Quantity affected
- 4484
- Distribution
- US (nationwide) and PR.
- Date initiated
- 2015-01-09
- Date posted
- 2015-01-29
- Date terminated
- 2017-08-23
- Location
- Reading, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CG+ ARROW PICC POWERED BY ARROW VPS STYLET (K122545) | Arrow International (Subsidiary of Teleflex Inc.) | 2012-09-20 |
| ARROW PICC POWERED BY ARROW VPS STYLET (K121941) | Arrow International (Subsidiary of Teleflex Inc.) | 2012-09-07 |