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Terminated

Porex Nostril Retainers, CAT #7241, Size 4, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA.

FDA Recall Z-1515-06 · Posted 2006-09-22

Recalling FirmPorex Surgical, Inc.
Recall StatusTerminated
Product CodeLYA
Date Initiated2006-07-11
Date Terminated2007-02-06
Product Quantity27 units

Reason for Recall

Device contains a trace amount of amine via introduction through an intermediate supplied by a third party raw material

Firm Action

Consignees were contacted by phone for product return and with a follow up in letter dated 07/12/2006.

Root Cause

Other

Distribution Pattern

Worldwide distribution ---- including states of AZ, CA, CT, DC, FL, NC, PA, WI and country of Germany. AZ, CA, CT, DC, FL, NC, PA, WI and Germany

Official Source

View FDA Recall →

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

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