Recall Z-0384-05 ยท MMP Cover, Barrier, Protective
Hydro Med Products, Inc
Ultrasound Probe Drape Tapered to 1.5' Sterile 8' x 60', Product Number 781-983; Manufactured by Hydo-Med Products Inc., 2930 Ladybird Ln., Dallas, TX 75220
| Date | Jan 6, 2005 (initiated Sep 28, 2000) |
| Status | Terminated |
| Reason | Defective packaging, potential for breech in sterility. |
| Root cause | Other |
| Action | The firm initiated the recall on 09/28/00 via letter. The firm followed up with phone call contact to 100% of customers. |
| Quantity | 35 cases, 10 units per case |
| Distribution | The product was distributed nationwide to distributors and hospitals in the following states IA, WV, OR, PA, CA, and TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K940151 | ULTRASOUND PROBE DRAPE Hydro-Med Products, Inc., Nov 14, 1994 |