CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Quebec, Canada. The produ
FDA device recall Z-0079-2007 · posted 2006-10-28 · Terminated
Recall details
- Recalling firm
- ATS Medical, Inc.
- Reason for recall
- Incorrect Expiration Date: Three lots of the FrostByte (TM) clamp packaged with SurgiFrost 7 cm cryosurgical probes have incorrect expiration dates. These lots are labeled with a two (2) year expiratation date while the correct date is one (1) year.
- Action taken
- Consignee''s were notified by ATS Medical Representatives via visits. Product was either relabeled with correct expiration date or retrieved by ATS Medical representatives.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEH
- Quantity affected
- 219 units
- Distribution
- Nationwide-ATS Medical distirubted devices to hospitals located in the following states IN, KS, MO, TX. There may be other US distributors of this product.
- Date initiated
- 2006-05-05
- Date posted
- 2006-10-28
- Date terminated
- 2006-11-02
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE (K053436) | Cryocath Technologies, Inc. | 2006-01-13 |