FDA Recall
Terminated
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
Recall: Z-1018-03
·
Initiated July 3, 2003
Recall
- Recall Number
- Z-1018-03
- Event Number
- 26613
- Firm
- Elite Medical Group
- FEI Number
- 3003812831
- Product Code
- MPN--
- Status
- Terminated
- Root Cause
- Other
- Initiated
- July 3, 2003
- Posted
- July 15, 2003
- Terminated
- January 23, 2004
- Address
- 2907 Gill Street, Bloomington, IL, 61704
Description
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
Reason
The liquid tissue adhesive was marketed without FDA pre-market clearance.
Action
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.
Distribution
Illinois, Tennessee, Kansas, Kentucky, Maryland and Missouri
Quantity
129 cases