Urethral Warming System-Galil Medical Warming Catheter. The product is contained within prostate kits. This product is u
FDA device recall Z-1698-2008 · posted 2008-09-03 · Terminated
Recall details
- Recalling firm
- Galil Medical
- Reason for recall
- The warming catheter was manufactured with the inlet and outlet tubes switched.
- Action taken
- The recalling firm telephoned their customers in April 2008 to inform them of the problem and the need to return the product. There customers were also asked to contact the firm if they had actually used any of the kits with the serial numbers listed, even if they experienced no problem. As a follow up to the telephone call, a letter was issued to the customers. For assistance, please call 770-565-6166.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GEH
- Quantity affected
- 541 catheters
- Distribution
- Worldwide Distribution --- USA including states of PA, SC, FL, NY, TN, and WA, and country of Canada
- Date initiated
- 2007-12-11
- Date posted
- 2008-09-03
- Date terminated
- 2008-09-02
- Location
- Plymouth Meeting, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1 (K012497) | Galil Medical , Ltd. | 2001-10-30 |