Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter
- Company
- Arrow International Inc.
- Recall Initiated
- August 10, 2023
- Posted
- September 15, 2023
- Recall Number
- Z-2591-2023
- Quantity
- 177 units
- Firm Location
- Morrisville, NC
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.
Distribution
US Nationwide distribution.
Lot / Code Info
Batch/Lot number 13F22E0359
Root Cause
Under Investigation by firm
Action Taken
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.