Medline Blue O.R. Towel, Sterile; Reorder MDT2168204; 4 towels per pack, 20 packs per case; Medline Industries, Inc., Mu
FDA device recall Z-0114-04 · posted 2003-11-13 · 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
- Medline telephoned their sales represntatives on 10/7/03, instructing them to visit their accounts who received lot 03IA0532 and retrieve all cases of the lot distributed due to a quality issue. The accounts were informed that replacement product would be provided for the returned product.
- Root cause
- Other
- Status
- Terminated
- Product code
- KKX
- Quantity affected
- 44 cases
- Distribution
- Ohio, Iowa, Illinois, Wisconsin and Indiana
- Date initiated
- 2003-10-07
- Date posted
- 2003-11-13
- Date terminated
- 2003-11-12
- 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 AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE (K962205) | Medline Industries, Inc. | 1996-11-26 |