CaverMap Surgical Aid Disposable Kit with Focused Probe Tip, Sterile Part Number: 8305
FDA device recall Z-1235-03 · posted 2003-09-13 · Terminated
Recall details
- Recalling firm
- Blue Torch Medical Technologies
- Reason for recall
- Product's sterility is compromised due to a failed sterility audit
- Action taken
- Blue TorchMedical notified 2 consignees by fax on 7/10/03, requesting return of unused inventory.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 20 units
- Distribution
- NY, TX
- Date initiated
- 2003-07-10
- Date posted
- 2003-09-13
- Date terminated
- 2003-10-22
- Location
- Ashland, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CAVERMAP SURGICAL AID (K000507) | Uromed Corp. | 2000-04-21 |
| CAVERMAP SURGICAL AID (K993436) | Uromed Corp. | 2000-02-11 |