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Terminated

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

FDA Recall Z-1156-06 · Posted 2006-06-22

Recalling FirmAdept-Med International Inc
Recall StatusTerminated
Product CodeGZC
Date Initiated2004-08-17
Date Terminated2006-12-28
Product Quantity7,600 units

Reason for Recall

Devices for which sterility may be compromised as evidenced by a loss of package integrity.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K870809MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206Adept-Med Intl., Inc. · 1987-03-19K802806VISECERA RETAINERAdept-Med Intl., Inc. · 1981-01-23

Official Source

View FDA Recall →

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

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