Arrow PICC Kit with Blue Flex Tip Catheter and Placement Wire. Catalog number PK-01552-WSSP
FDA Recall Z-0551-05 · Posted 2005-02-18
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Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeLJS
Date Initiated2004-09-21
Date Terminated2005-05-04
Product Quantity25 kits
Reason for Recall
Product was mislabeled for lumen configuration, flow rates, and priming volume.
Firm Action
The recalling firm telephoned the hospital accounts on 9/21/04 to inform them of the problem and the need to return the product. As a follow up to the telephone calls, a recall letter dated 9/21/04 was sent via FedEx to the hospitals.
Root Cause
Other
Distribution Pattern
The products were shipped to hospitals in AZ, CA, NJ, and WV.
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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