Recall Z-2883-2011 ยท MSD Catheter, Hemodialysis, Implanted
Arrow International Inc
Arrow NextStep Antegrade Chronic Hemodialysis Catheter. Product is used for attaining long-term vascular access for hemodialysis and apheresis.
| Date | Jul 30, 2011 (initiated Jun 28, 2011) |
| Status | Terminated |
| Reason | Firm has received complaints indicating breakage and/or separation of the stylet within the Arrow(R) NextStep(R) Antegrade Catheters. |
| Root cause | Device Design |
| Action | An "Urgent Medical Device Recall" letter dated June 28, 2011 was issued to consignees. The letter requested that customers check their stock, cease use and distribution, and quarantine all affected product. Consignees were further directed to complete the "Recall Acknowledgement & Stock Status Form", return the form to their sales representative, and return affected product as instructed on the letter. For questions or concerns, call 1-800-233-3187. |
| Quantity | 41 |
| Distribution | United States (states of CA, DE, FL, MI, NC, and TN). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102238 | ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER Teleflexmedical, Inc., Feb 1, 2011 |