Recall Z-0644-03 ยท GBX Catheter, Irrigation
Medline Industries Inc
Sterile 8 Fr Suction Catheter Kit - Latex Free; Medline Industries, Inc., Mundelein, IL 60060-4488; 50 kits per case
| Date | Mar 12, 2003 (initiated Feb 12, 2003) |
| Status | Terminated |
| Reason | Some of the kits labeled as latex free contain latex gloves which are properly labeled. |
| Root cause | Other |
| Action | 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. |
| Quantity | 753 cases |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K822510 | SUCTION CATHETER W/STERILE WATER Medine Dynacor, Oct 13, 1982 |