Recall Z-2701-2011
Codman & Shurtleff, Inc. · initiated March 21, 2011
Product
CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System 4.5mm x 28mm Product code: ENF452812
Codes / lots: Lot Numbers: 01420432, 01420851, 01421192, 01421315, 01421338, 01421601, 01421949, 01422123, 01422396, 01422401, 02420432, VV1419796
Reason for recall
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.
FDA-determined cause: Labeling design
Action taken
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
Details
- Recall number
- Z-2701-2011
- Initiated
- March 21, 2011
- Posted by FDA
- June 29, 2011
- Terminated
- February 17, 2016
- Product code
- NJE – Intracranial Neurovascular Stent
- Quantity
- 380 units
- Distribution
- Worldwide - Nationwide (USA), Canada, Korea.
- Recalling firm
- Codman & Shurtleff, Inc., Raynham, MA