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U.S. Department of Health and Human Services

Class 2 Device Recall Helitene Absorbable Collagen Hemostatic Sponge

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  Class 2 Device Recall Helitene Absorbable Collagen Hemostatic Sponge see related information
Date Initiated by Firm March 28, 2013
Date Posted May 10, 2013
Recall Status1 Terminated 3 on June 03, 2015
Recall Number Z-1290-2013
Recall Event ID 64778
PMA Number P850010 
Product Classification Agent, absorbable hemostatic, collagen based - Product Code LMF
Product Helitene Absorbable Collagen Hemostatic Sponge

Helitene is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Code Information 1110788, 1112217 1110222, 1111357 1111602, 1105255 1110224, 1110225 1111601, 1110223 1110790, 1111603
Recalling Firm/
Manufacturer		 Integra LifeSciences Corporation
105 Morgan Ln
Plainsboro NJ 08536-3339
For Additional Information Contact
609-275-2700
Manufacturer Reason
for Recall		 Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
FDA Determined
Cause 2		 Process control
Action The firm, Integra, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated April 9, 2013, to all US, Canada, and non-EU Integra consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to verify if they have any lots of the listed product, if so, STOP using that product; remove the product from service; and promptly complete and return the PRODUCT RECALL RETURN ACKNOWLEDGMENT FORM via Email: FCA@integralife.com or FAX to : 1-609-275-9445. Customer Service department will contact you to return and replace the product. "However, if you have already implanted or used collagen sponge products affected by this recall, we recommend you monitor the patient for a fever in the immediate postoperative period according to the standard hospital or clinician protocol." For assistance or any other questions that you may have, please contact Customer Service at 1-855-532-1723.
Quantity in Commerce 14, 525 boxes
Distribution Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
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.
PMA Database PMAs with Product Code = LMF and Original Applicant = INTEGRA LIFESCIENCES CORPORATION
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