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
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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
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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 |
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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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