FDA Device

Acclarent brand Relieva Sinus Inflation Device Kit; Model BID30; The kit contains 1 inflation device, 1-10'' extension tube, 1-20cc syringe, 3-way stop-cock; Manufactured for Acclarent, Inc., 1525-B O''Brien Dr., Menlo Park, CA 94025

Hazard

Device sterility may be compromised as evidenced by a loss of package integrity.

What You Should Do

Remedy

On 1/20/06 the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.

Products

Acclarent brand Relieva Sinus Inflation Device Kit; Model BID30; The kit contains 1 inflation device, 1-10'' extension tube, 1-20cc syringe, 3-way stop-cock; Manufactured for Acclarent, Inc., 1525-B O
Brand
Acclarent Inc
UPC
Catalog #, Lot #, Manufacture Date, Expiration Date: BID30, 99456168, 09/2005, 09/2010, BID30,99455806, 08/2005, 08/2010, BID30, 99455018, 08/2005, 08/2010, BID30, 99458283, 09/2005, 09/2010, BID30, 99457941, 10/2005, 10/2010, BID30, 99464320, 12/2005, 10/2008, BID30,,99464317, 11/2005, 11/2010

Units Affected

149 units