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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 May 12, 2016
Date Posted May 31, 2016
Recall Status1 Terminated 3 on March 23, 2017
Recall Number Z-1838-2016
Recall Event ID 74139
PMA Number P030039 
Product Classification Sealant,polymerizing - Product Code NBE
Product COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Code Information HA160136
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp
21026 Alexander Ct
Hayward CA 94545-1234
For Additional Information Contact
800-422-9837
Manufacturer Reason
for Recall		 Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action An Urgent Product Recall letter dated 5/13/16 was sent to customers to inform them that Baxter Healthcare Corporation is issuing a voluntary product recall for the product codes and lots listed below due to the potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use. The letter provides the customers with the list of affected products, hazards involved, and actions to be taken. Customers with questions regarding the recall communication, are instructed to contact Baxter Product Surveillance at (800) 437-5176, 8-5pm, Monday-Friday.
Quantity in Commerce 274 units
Distribution Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.
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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