Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
FDA Recall Z-2590-2023 · Posted 2023-09-15
Recalling FirmARROW INTERNATIONAL Inc.
Recall StatusOpen, Classified
Product CodeLJS
Date Initiated2023-08-10
Product Quantity190 units
Reason for Recall
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Firm Action
Teleflex/Arrow International issue an URGENT MEDICAL DEVICE RECALL notice on 08/10/2023 by FedEx 2nd day mail. The letter explained the problem, risk to patient, and requested the following actions:
Medical facilities:
Immediately cease use and distribution of affected product and quarantine for return.
Distributors:
Immediately cease use and distribution of affected product and quarantine for return. Provide a copy of this recall notice to all customers who have received impacted product. Request they complete the Acknowledgement Form and return it to you.
Firm is requesting return of the affected product.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution.
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.