Recall Z-0079-2007 ยท GEH Unit, Cryosurgical, Accessories
ATS Medical, Inc.
CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Quebec, Canada. The product consists of a cryosurgical probe (SurgiFrost 7 cm) plus Clamp (FrostByte) packaged for use with Cryosurgical console.
| Date | Oct 28, 2006 (initiated May 5, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Consignee''s were notified by ATS Medical Representatives via visits. Product was either relabeled with correct expiration date or retrieved by ATS Medical representatives. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053436 | SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE Cryocath Technologies, Inc., Jan 13, 2006 |