COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemos

FDA device recall Z-1838-2016 · posted 2016-05-31 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

NBE

Quantity affected

274 units

Distribution

Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.

Date initiated

2016-05-12

Date posted

2016-05-31

Date terminated

2017-03-23

Location

Hayward, CA