Z-1156-06

Adept-Med brand Glassman Viscera Retainer FISH Sterile, Item Numbers: 3204, 3202, 3203, 3202, 3201, 3200...

Name: Z-1156-06 Adept-Med brand Glassman Viscera Retainer FISH Sterile, Item Numbers: 3204, 3202, 3203, 3202, 3201, 3200...
Creator: Adept-Med International Inc
Published: 2004-08-17
License: https://open.fda.gov/license/

Adept-Med Intl., Inc. / initiated 2004-08-17 / Terminated / root cause: packaging

FDA source

Adept-Med International Inc began a recall of Adept-Med brand Glassman Viscera Retainer FISH Sterile, Item Numbers: 3204, 3202, 3203, 3202, 3201, 3200, 3206; Product is manufactured and distributed by... on 2004-08-17. The reason FDA records is "Devices for which 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-1156-06
Status: Terminated
Initiated: 2004-08-17
Posted: 2006-06-22
Terminated: 2006-12-28
Recalling firm: Adept-Med Intl., Inc.
Product: Adept-Med brand Glassman Viscera Retainer FISH Sterile, Item Numbers: 3204, 3202, 3203, 3202, 3201, 3200, 3206; Product is manufactured and distributed by Adept-Med International, Inc., 665 Pleasant Valley Rd., Diamond Springs, CA 95619
Product code: GZC Stimulator, Neuromuscular, Implanted
Reason for recall: Devices for which sterility may be compromised as evidenced by a loss of package integrity.
Root cause tag: packaging
FDA root cause: Other
Action: On 8/13/04, 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: 7,600 units
Distribution: Nationwide-The product was released for distribution to 249 consignees in US. The firm identified 242 hospitals and 7 distributors. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, pharmacists, hospitals who received the recalled product.
Product codes and lots: 1104, 1204, 11203, 11103, 11503, 11403, 10503

Product code GZC

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)