Adept-Med brand Glassman Viscera Retainer FISH Sterile, Item Numbers: 3204, 3202, 3203, 3202, 3201, 3200, 3206; Product
FDA device recall Z-1156-06 · posted 2006-06-22 · Terminated
Recall details
- Recalling firm
- Adept-Med International Inc
- Reason for recall
- Devices for which sterility may be compromised as evidenced by a loss of package integrity.
- Action taken
- 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
- Status
- Terminated
- Product code
- GZC
- Quantity affected
- 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.
- Date initiated
- 2004-08-17
- Date posted
- 2006-06-22
- Date terminated
- 2006-12-28
- Location
- Diamond Springs, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206 (K870809) | Adept-Med Intl., Inc. | 1987-03-19 |
| VISECERA RETAINER (K802806) | Adept-Med Intl., Inc. | 1981-01-23 |