Recall Z-1592-2010

Reason for recall

Potential problem with pouch seal thus affecting sterile product.

FDA-determined cause: Packaging process control

Action taken

Firm notified distributor by telephone 2/8/2010. Firm and distributor partnered to notify customers by an Urgent: Medical Device Recall - Lot Specific letter, dated 2/10/2010, beginning 2/16/2010. The letter identified the affected product and the reason for the recall. The letter asked customers to immediately check their inventory remove any affected kits and place them in a secure location. Customers are to complete the Product Recall Inventory Form and fax it to the Customer Service Department. Customers are also to contact Customer Service for a Return Authorization Number at 1-866-240-6001. Affected products will be replaced upon receipt. Questions or concerns should be directed to a local Sales Representative or Jill Eisenzimmer, Product Manager, at 763-656-4300.