Z-1018-03

MSI-EpiDermGlu (Iso-Butyl 2 Cyanoacrylate) tissue adhesive for soft tissue approximation; 0.22 cc plastic...

Name: Z-1018-03 MSI-EpiDermGlu (Iso-Butyl 2 Cyanoacrylate) tissue adhesive for soft tissue approximation; 0.22 cc plastic...
Creator: Elite Medical Group
Published: 2003-07-03
License: https://open.fda.gov/license/

Elite Medical Group / initiated 2003-07-03 / Terminated

FDA source

Elite Medical Group began a recall of 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... on 2003-07-03. The reason FDA records is "The liquid tissue adhesive was marketed without FDA pre-market clearance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1018-03
Status: Terminated
Initiated: 2003-07-03
Posted: 2003-07-15
Terminated: 2004-01-23
Recalling firm: Elite Medical Group
Product: 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
Product code: MPN--
Reason for recall: The liquid tissue adhesive was marketed without FDA pre-market clearance.
FDA 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 in commerce: 129 cases
Distribution: Illinois, Tennessee, Kansas, Kentucky, Maryland and Missouri
Product codes and lots: Product #51002, all lots

Product code MPN--

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)