Elasto-Gel Wound Dressings, 3 product codes: DR8050, DR 8000, and DR 8000LV (for foreign distribution only), 4'' x 4'',
FDA device recall Z-0841-06 · posted 2006-05-04 · Terminated
Recall details
- Recalling firm
- Southwest Technologies Inc
- Reason for recall
- The product is labeled as sterile and one of the lots failed sterility during the quarterly radiation dose audit.
- Action taken
- Recall letters were sent to all direct accounts via certified mail on 3/27/2006. The consignees were requested to return any affected product on hand and if the product was further distributed, notify their customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRO
- Quantity affected
- 90 cases of Product DR8000; 56 cases or Product DR8000LV; and 28 cases of Product DR8050. Each case contained 100 units.
- Distribution
- Product was distributed to direct accounts in the United States and Belgium.
- Date initiated
- 2006-03-27
- Date posted
- 2006-05-04
- Date terminated
- 2007-12-12
- Location
- N Kansas City, MO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELASTO-GEL OCCLUSIVE DRESSING (K872165) | Southwest Technologies, Inc. | 1987-06-26 |