Medline Premium Wet Skin Prep Tray, Sterile, Latex Free; a single use surgical convenience tray, EO sterilized; Reorder
FDA device recall Z-0268-2007 · posted 2006-12-14 · Terminated
Recall details
- Recalling firm
- Medline Industries Inc
- Reason for recall
- The product, labeled as sterile, had not gone through the sterilization process at the time of shipment.
- Action taken
- On 11/21/06, Medline telephoned the accounts who may have received the recalled lots, informing them that the skin scrub trays may not have gone through the full manufacturing cycle and are not sterile. They were requested to check their inventories for the two affected lots, removing any found from inventory and placing it on hold for return to Medline. The accounts were then sent a recall letter via fax on the same date, reiterating the telephone calls, and requesting the accounts to complete and fax back the attached response form, indicating amount of each lot placed on hold. Any questions were directed to Medline''s recall hotline at 866-359-1704.
- Root cause
- Other
- Status
- Terminated
- Product code
- LRO
- Quantity affected
- 47 cases
- Distribution
- Minnesota, Illinois, Wisconsin and Indiana
- Date initiated
- 2006-11-21
- Date posted
- 2006-12-14
- Date terminated
- 2008-01-31
- Location
- Mundelein, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STERILE DISPOSABLE WET SKIN SCRUB TRAY (K914174) | Medical Device Inspection Co., Inc. | 1992-02-24 |