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