Ultrasound Probe Drape Tapered to 1.5' Sterile 8' x 60', Product Number 781-983; Manufactured by Hydo-Med Products Inc.,
FDA device recall Z-0384-05 · posted 2005-01-06 · Terminated
Recall details
- Recalling firm
- Hydro Med Products, Inc
- Reason for recall
- Defective packaging, potential for breech in sterility.
- Action taken
- The firm initiated the recall on 09/28/00 via letter. The firm followed up with phone call contact to 100% of customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- MMP
- Quantity affected
- 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
- Date initiated
- 2000-09-28
- Date posted
- 2005-01-06
- Date terminated
- 2008-04-01
- Location
- Dallas, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ULTRASOUND PROBE DRAPE (K940151) | Hydro-Med Products, Inc. | 1994-11-14 |