Integra Container Lid, Size, Red; Container Lid, Size, Blue; Container Lid, Size, Red; Container Lid, Size, Gold; Contai
FDA device recall Z-2624-2014 · posted 2014-09-11 · Terminated
Recall details
- Recalling firm
- Integra York PA, Inc
- Reason for recall
- Integra LifeSciences has identified through an internal investigation that some colored lids for Integra container systems were not yet cleared by the FDA for sale and were inadvertently distributed.
- Action taken
- Integra sent an Urgent Voluntary Medical Device Recall letter dated July 30, 2014, to the affected customer. The letter identified the product, the problem, and the action to be taken by the customer. The customer was instricted if they have distributed the affected product, they should identify those customers adn forward a copy of the Integra Medical Device Recall Notice to them. The customer was also instructed to complete the attached form and return by email FCA@integralife.come or FAX to 1-609-275-9445. For questions the customer was asked to contact Customer Service at 1-855-532-1723. For questions regarding this recall call 717-840-9335.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- KCT
- Quantity affected
- 84
- Distribution
- US only to one repacker/relabeler and three medical facilities. The relabeler was identified as: KLS Martin, 11201 St. Johns Industrial Parkway S, Jacksonville, FL 32246 (904) 641-7746
- Date initiated
- 2014-07-30
- Date posted
- 2014-09-11
- Date terminated
- 2015-03-10
- Location
- York, PA
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