Porex Nostril Retainers, CAT #7241, Size 4, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA.
FDA device recall Z-1515-06 · posted 2006-09-22 · Terminated
Recall details
- Recalling firm
- Porex Surgical, Inc.
- Reason for recall
- Device contains a trace amount of amine via introduction through an intermediate supplied by a third party raw material
- Action taken
- Consignees were contacted by phone for product return and with a follow up in letter dated 07/12/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- LYA
- Quantity affected
- 27 units
- Distribution
- 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
- Date initiated
- 2006-07-11
- Date posted
- 2006-09-22
- Date terminated
- 2007-02-06
- Location
- Newnan, GA
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