Z-0559-06

Acclarent brand Relieva Sinus Inflation Device Kit; Model BID30; The kit contains 1 inflation device, 1-10''...

Name: Z-0559-06 Acclarent brand Relieva Sinus Inflation Device Kit; Model BID30; The kit contains 1 inflation device, 1-10''...
Creator: Acclarent Inc
Published: 2006-01-20
License: https://open.fda.gov/license/

Acclarent Inc / initiated 2006-01-20 / Terminated / root cause: packaging

FDA source

Acclarent Inc began a recall of 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... on 2006-01-20. The reason FDA records is "Device sterility may be compromised as evidenced by a loss of package integrity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0559-06
Status: Terminated
Initiated: 2006-01-20
Posted: 2006-02-24
Terminated: 2006-05-11
Recalling firm: Acclarent Inc
Product: 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
Product code: LRC Instrument, Ent Manual Surgical
Reason for recall: Device sterility may be compromised as evidenced by a loss of package integrity.
Root cause tag: packaging
FDA root cause: Other
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.
Quantity in commerce: 149 units
Distribution: 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
Product codes and lots: 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

Product code LRC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)