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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

FDA Recall Z-1018-03 · Posted 2003-07-15

Recalling FirmElite Medical Group
Recall StatusTerminated
Product CodeMPN
Date Initiated2003-07-03
Date Terminated2004-01-23
Product Quantity129 cases

Reason for Recall

The liquid tissue adhesive was marketed without FDA pre-market clearance.

Firm 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.

Root Cause

Other

Distribution Pattern

Illinois, Tennessee, Kansas, Kentucky, Maryland and Missouri

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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