Arrow ErgoPack PICC (Arrow) – Product Label Mismatch (2023)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter
Brand
ARROW INTERNATIONAL Inc.
Lot Codes / Batch Numbers
Batch/Lot number 33F23B0781
Products Sold
Batch/Lot number 33F23B0781
ARROW INTERNATIONAL Inc. is recalling Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS due to This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026