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U.S. Department of Health and Human Services

Class 2 Device Recall Integra

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  Class 2 Device Recall Integra see related information
Date Initiated by Firm July 30, 2014
Date Posted September 11, 2014
Recall Status1 Terminated 3 on March 10, 2015
Recall Number Z-2624-2014
Recall Event ID 68954
510(K)Number K102146  K112090  
Product Classification Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
Product 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.
Code Information 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
Recalling Firm/
Manufacturer		 Integra York PA, Inc
589 Davies Dr
York PA 17402-8630
For Additional Information Contact Customer Support
717-840-9335
Manufacturer 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.
FDA Determined
Cause 2		 Employee error
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 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.
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KCT and Original Applicant = BAHADIR USA CORP.
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