MSI-EpiDermGlu (Iso-Butyl 2 Cyanoacrylate) tissue adhesive for soft tissue approximation; 0.22 cc plastic squeeze tubes packaged in a Tyvek/PPE pouch with paper label, 10 units per case; Manufactured by Medisav Services Inc. (MSI), 56 Elson Street, Markham, Ontario L3S 1Y7 Canada
- Company
- Elite Medical Group
- Recall Initiated
- July 3, 2003
- Posted
- July 15, 2003
- Terminated
- January 23, 2004
- Recall Number
- Z-1018-03
- Quantity
- 129 cases
- Firm Location
- Bloomington, IL
Reason for Recall
The liquid tissue adhesive was marketed without FDA pre-market clearance.
Distribution
Illinois, Tennessee, Kansas, Kentucky, Maryland and Missouri
Lot / Code Info
Product #51002, all lots
Root Cause
Other
Action Taken
Recalled by letter dated 7/2/03, informing the accounts that the skin adhesive had not been approved for marketing in the United States and that they should return the product to Elite Medical.