Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percut
FDA device recall Z-2591-2023 · posted 2023-09-15 · Open, Classified
Recall details
- Recalling firm
- ARROW INTERNATIONAL Inc.
- 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.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LJS
- Quantity affected
- 177 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2023-08-10
- Date posted
- 2023-09-15
- Location
- Morrisville, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARROW PICC POWERED BY ARROW VPS STYLET (K121941) | Arrow International (Subsidiary of Teleflex Inc.) | 2012-09-07 |