FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1018-03
- 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
- Status
- Terminated
- Initiated
- 2003-07-03
- Posted
- 2003-07-15
- Terminated
- 2004-01-23
- 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
- Lot, serial or model codes
- Product #51002, all lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MPN--
- Firm FEI
- 3003812831
- Firm city
- Bloomington
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28