Medi-Tech Magic Torque Glidex hydrophilic coated guidewire, .035 inch/180 cm and .035 inch/260 cm lengths. Packaged in a sterile pouch and a three pack shelf box.
This recall has been terminated (originally issued March 20, 2003).
- Company
- Symbiosis Corp.
- Recall Initiated
- November 27, 2002
- Posted
- March 20, 2003
- Terminated
- July 13, 2012
- Recall Number
- Z-0666-03
- Quantity
- 286
- Firm Location
- Miami, FL
- Official Source
- View on FDA website ↗
Reason for Recall
The 180 cm guidewire is mislabeled as 260 cm and the 260 cm guidewire is mislabeled as 180 cm.
Distribution
Product was distributed to 118 hospitals nationwide.
Lot / Code Info
Pouch codes for the 180 cm length wuidewires are: Catalog No. 46-591, UPN M001465910 Lot Number Use Before Date 4959940 2005-08 4959941 '' 4969651 '' 4969654 '' 4969655 '' 4969656 '' The pouch codes for the 260 cm length guidewires are: Catalog No. 46-5912, UPN M001465920 Lot Number Use Before Date 4959945 2005-08 4959946 '' 4959944 '' 4959943 ''
Root Cause
Other
Action Taken
A Recall Notification Letter was send to hospitals via Federal Express Overnight Delivery, on 11/27/2002 to the attention of the Risk Manager and the Cath Lab Manager. In addition a response form was included. Recalled units are to be returned to the Boston Scientific Distribution Center located at 500 Commander Shea Blvd., Quincy, MA 02171.