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U.S. Department of Health and Human Services

Class 2 Device Recall Coseal Surgical Sealant.

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  Class 2 Device Recall Coseal Surgical Sealant. see related information
Date Initiated by Firm July 28, 2011
Date Posted May 16, 2012
Recall Status1 Terminated 3 on May 31, 2012
Recall Number Z-1614-2012
Recall Event ID 59861
PMA Number P030039 
Product Classification Sealant,polymerizing - Product Code NBE
Product Coseal Surgical Sealant.

Coseal is an adjunctive surgical sealant.
Code Information Lot numbers: (2mL) HA100143, HA091236. (4mL) HA090950, HA090944, HA090843, HA090749, HA090947. (8mL) HA100132, HA100142
Recalling Firm/
Manufacturer		 Baxter Healthcare Services L.P.
1 Baxter Pkwy
Building 3
Deerfield IL 60015-4625
For Additional Information Contact
847-940-5061
Manufacturer Reason
for Recall		 The recall is being conducted as a precautionary measure due to out of specification results observed at the 24 months time point (out of 24-month licensed shelf life to expiration) during a Coseal stability study. The parameter that is out specification is an indicator of possible failure for the product to gel appropriately . Coseal's failure to gel does not represent risk for the patient's life
FDA Determined
Cause 2		 Device Design
Action Baxter Healthcare sent an"URGENT PRODUCT RECALL" letter dated July 27, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately stop the usage/distribution of the affected product and to quarantine any units that are in inventory. Instructions for obtaining replacement product were attached to the letter. Contact the firm at 1-800-423-2090 for questions concerning this recall.
Quantity in Commerce 11160
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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