Date Initiated by Firm | January 14, 2010 |
Date Posted | July 02, 2010 |
Recall Status1 |
Terminated 3 on December 22, 2010 |
Recall Number | Z-1949-2010 |
Recall Event ID |
55825 |
PMA Number | P030039 |
Product Classification |
Polymerizing Sealant - Product Code NBE
|
Product | Coseal Surgical Sealant 4mL, Product Codes: 934071 & 934074.
Indicated for use in vascular reconstructions to achieve adjunctive hemostasis. |
Code Information |
Lot Numbers: HA080942, HA080943, HA081001E, HA081046E, HA081102, HA081132, HA081235, HA090139, HA090241, & HA090342. |
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 | 15,262 |
Distribution | Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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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.
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PMA Database | PMAs with Product Code = NBE
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