Sterile 8 Fr Suction Catheter Kit - Latex Free; Medline Industries, Inc., Mundelein, IL 60060-4488; 50 kits per case
FDA device recall Z-0644-03 · posted 2003-03-12 · Terminated
Recall details
- Recalling firm
- Medline Industries Inc
- Reason for recall
- Some of the kits labeled as latex free contain latex gloves which are properly labeled.
- Action taken
- Recalled by letter dated 2/11/03. The accounts were informed that some of the suction catheter trays labeled as latex free actually contained latex gloves. The latex glove wrapper has a latex warning on it. The accounts were instructed to return any of the suspect lot of trays to Medline for replacement or credit. The recall was expanded by letterdated 3/3/03 to include the one lot of dressing change trays for the same problem and the same instructions.
- Root cause
- Other
- Status
- Terminated
- Product code
- GBX
- Quantity affected
- 753 cases
- Distribution
- Nationwide and Canada
- Date initiated
- 2003-02-12
- Date posted
- 2003-03-12
- Date terminated
- 2003-08-12
- 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 |
|---|---|---|
| SUCTION CATHETER W/STERILE WATER (K822510) | Medine Dynacor | 1982-10-13 |