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Terminated

Integra Container Lid, Size, Red; Container Lid, Size, Blue; Container Lid, Size, Red; Container Lid, Size, Gold; Container Lid, Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524, 730621, 730622 The Integra Sterilization Container is intended for use in hospitals and healthcare facilities to contain other medical devices that are to be steam sterilized (autoclaved) by the facility prior to use. Sterilized devices may be stored and transferred within the facility in the container per the healthcare facilities protocols. Integra provides these items to users as either as a tray and lid combination, just a tray, or just a lid.

FDA Recall Z-2624-2014 · Posted 2014-09-11

Recalling FirmIntegra York PA, Inc
Recall StatusTerminated
Product CodeKCT
Date Initiated2014-07-30
Date Terminated2015-03-10
Product Quantity84

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.

Firm Action

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 [email protected] 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

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112090BAHADIR STERILIZATION TRAYSBahadir USA Corp. · 2012-06-07K102146BAHADIR STERILIZATION TRAYSBahadir USA Corp. · 2010-11-18

Official Source

View FDA Recall →

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

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