Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.
FDA Recall Z-1965-2013 · Posted 2013-08-14
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Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeDQY
Date Initiated2013-07-31
Date Terminated2015-04-28
Product Quantity156
Reason for Recall
Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen.
Firm Action
An "Urgent Medical Device Recall Notification" letter dated July 31, 2013 was sent to direct accounts requesting immediate discontinuation of use and quarantine of all affected product on hand. Negative responses were also requested and the immediate return of product to Arrow was authorized. Questions were directed to Customer Service at 800 343-2935.
Root Cause
Labeling Change Control
Distribution Pattern
AL, PA, CT, NC, VA, KS, RI, AZ, NJ, and IL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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