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Terminated

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

FDA Recall Z-0559-06 · Posted 2006-02-24

Recalling FirmAcclarent Inc
Recall StatusTerminated
Product CodeLRC
Date Initiated2006-01-20
Date Terminated2006-05-11
Product Quantity149 units

Reason for Recall

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

Firm Action

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.

Root Cause

Other

Distribution Pattern

The product was released for distribution to 15 consignees in US. The recall was appropriately extended to the consumer/user level; i.e., the direct accounts (users) who received the recalled product. There is one Veterans Affairs account: Dept. of Veterans Affairs Medical Center PA, 1 215 823-4659, University & Woodland Avenues, Philadelphia, PA 19104, USA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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