Recall Z-2701-2011 ยท NJE Intracranial Neurovascular Stent
Codman & Shurtleff, Inc.
CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System 4.5mm x 28mm Product code: ENF452812
| Date | Jun 29, 2011 (initiated Mar 21, 2011) |
| Status | Terminated |
| Reason | Mislabeled: One of the stick on stickers on the sterile pouch inside of the product box indicates the stent size to be 22mm in length, when in fact the product is 28mm in length. |
| Root cause | Labeling design |
| Action | Codman & Shurtleff, Inc.sent an "Urgent Medical Device Correction Notice" on March 21, 2011. The letter recommend the incorrect label be removed and discarded. There are 3 additional peel-off labels, 2 on the outer box and one on the pouch. All 3 of these contain the correct printed size information (28 mm) that can be used for applying to the inventory sheet, patient record or patient card, as needed. It is NOT required to return any of this product to Codman. Customer Service at 1-800-225-0460 or contact your local Codman Neurovascular Representative |
| Quantity | 380 units |
| Distribution | Worldwide - Nationwide (USA), Canada, Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.