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U.S. Department of Health and Human Services

Class 2 Device Recall Coseal Surgical Sealant (COH102 & COH 206)

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  Class 2 Device Recall Coseal Surgical Sealant (COH102 & COH 206) see related information
Date Initiated by Firm January 14, 2010
Date Posted July 02, 2010
Recall Status1 Terminated 3 on December 22, 2010
Recall Number Z-1950-2010
Recall Event ID 55825
PMA Number P030039 
Product Classification Polymerizing Sealant - Product Code NBE
Product Coseal Surgical Sealant 8mL, Product Codes: 934072 & 934075.

Indicated for use in vascular reconstructions to achieve adjunctive hemostasis.
Code Information Lot Number: HA080901, HA080902, HA081002, HA081047, HA081218, & HA090112. 
Recalling Firm/
Manufacturer		 Baxter Bioscience
1 Baxter Way
Westlake Village CA 91362-3811
Manufacturer Reason
for Recall		 The recall is being conducted as a precautionary measure due to out of specification results at the 18 month and 21 month time points (out of the 24 month licensed shelf life to expiration) for the percent thiol substitution during a Coseal Stability study. The parameter that is out of specification is an indicator of possible failure for the product to gel appropriately.
FDA Determined
Cause 2		 Process control
Action The recall notification was initiated on January 14, 2010 with the firm sending a Product Recall letter and attached Customer Reply Form to the affected consignees. The recall letter informed the consignees of the reason for recall and requested them to immediately stop the usage/distribution of the lots noted above and to quarantine any units you may still have in your inventory. The letter provided instruction for product return. The letter also requested the consignees to please forward the recall information as appropriate to other services/facilities/departments that they may have provided this product to. Consignees were instructed to complete the Customer Reply Form, and fax it as soon as possible to 888-345-4261. Consignees with questions were instructed to contact Stericycle at 877-870-4486.
Quantity in Commerce 7,409
Distribution Nationwide Distribution
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 = NBE and Original Applicant = BAXTER BIO SCIENCE
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