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Terminated

Apligraf (Graftskin)

FDA Recall Z-0068-2007 · Posted 2006-10-24

Recalling FirmOrganogenesis, Inc.
Recall StatusTerminated
Product CodeMGR
Date Initiated2006-09-29
Date Terminated2007-03-12
Product Quantity58

Reason for Recall

Product pH out of specification

Firm Action

Organogenesis notified customers by fax on 9/29/06 through 10/2/06. Follow-Up telephone calls are being made. Users are requested to examine units for pH and return if product is out of spec., or verify unit was in spec for pH at time of use.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

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