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U.S. Department of Health and Human Services

Class 2 Device Recall INSTAT

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 Class 2 Recall
INSTAT
see related information
Date Posted May 10, 2013
Recall Status1 Open
Recall Number Z-1288-2013
Recall Event ID 64778
Premarket Approval
PMA Number
P830079
Product Classification Agent, Absorbable Hemostatic, Collagen Based - Product Code LMF
Product INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostatis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Code Information 1105177, 1105178 1110143, 1110227 1110228, 1110229 1110230, 1110233 1110786, 1110787 1111356, 1105179 111023 1, 1110232 1110785
Recalling Firm/
Manufacturer
Integra LifeSciences Corporation
105 Morgan Ln
Plainsboro, New Jersey 08536-3339
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
PRODUCTION CONTROLS: 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 17, 616 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LMF and Applicant = ETHICON, INC.
PMAs with Product Code = LMF and Applicant = JOHNSON & JOHNSON INTERNATIONAL
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