CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System 4.5mm x 28mm Product code: ENF452812
This recall has been terminated (originally issued June 29, 2011).
- Company
- Codman & Shurtleff, Inc.
- Recall Initiated
- March 21, 2011
- Posted
- June 29, 2011
- Terminated
- February 17, 2016
- Recall Number
- Z-2701-2011
- Quantity
- 380 units
- Firm Location
- Raynham, MA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide - Nationwide (USA), Canada, Korea.
Lot / Code Info
Lot Numbers: 01420432, 01420851, 01421192, 01421315, 01421338, 01421601, 01421949, 01422123, 01422396, 01422401, 02420432, VV1419796
Root 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