Recall Z-1018-03 ยท MPN Tissue Adhesive For The Topical Approximation Of Skin
Elite Medical Group
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
| Date | Jul 15, 2003 (initiated Jul 3, 2003) |
| Status | Terminated |
| Reason | The liquid tissue adhesive was marketed without FDA pre-market clearance. |
| Root cause | Other |
| 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. |
| Quantity | 129 cases |
| Distribution | Illinois, Tennessee, Kansas, Kentucky, Maryland and Missouri |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.