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Terminated

Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing

FDA Recall Z-1030-2015 · Posted 2015-01-29

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeOBJ
Date Initiated2015-01-09
Date Terminated2017-08-23
Product Quantity4484

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.

Firm Action

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

Distribution Pattern

US (nationwide) and PR.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122545CG+ ARROW PICC POWERED BY ARROW VPS STYLETArrow International (Subsidiary of Teleflex Inc.) · 2012-09-20K121941ARROW PICC POWERED BY ARROW VPS STYLETArrow International (Subsidiary of Teleflex Inc.) · 2012-09-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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