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Terminated

Integra Dermal Regeneration Template-TS Catalog number 32021 Catalog number 82021

FDA Recall Z-1035-2009 · Posted 2009-03-06

Recalling FirmIntegra LifeSciences Corp
Recall StatusTerminated
Product CodeMDD
Date Initiated2009-01-16
Date Terminated2009-06-25
Product Quantity31 units

Reason for Recall

Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained.

Firm Action

Urgent: Product Recall Notification letters were sent on January 21, 1009 via Federal Express. The letter asked customers to immediately quarantine any stock on hand and contact their local Integra Sales Representative for further assistance and arrangement of product returns. The enclosed "Recall Acknowledgement and Return Form" indicating whether or not customers possess any of the affected product should also be completed and returned. Company is conducting recall to the hospital level. Questions should be directed to Judy O'Grady at 609-936-2317.

Root Cause

Pending

Distribution Pattern

Nationwide Distribution -- including states of FL, CA, GA, FL, CT, MT, IL, TX, WA, TN, NC, IN, AZ, MD, CO, MO, and TN.

Official Source

View FDA Recall →

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

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