Z-0079-2007

CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Quebec...

Name: Z-0079-2007 CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Quebec...
Creator: ATS Medical, Inc.
Published: 2006-05-05
License: https://open.fda.gov/license/

Medtronic, Inc. (Minneapolis, MN 55447) / initiated 2006-05-05 / Terminated / root cause: labeling and UDI

FDA source

ATS Medical, Inc. began a recall of CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Quebec, Canada. The product consists of a cryosurgical probe... on 2006-05-05. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0079-2007
Status: Terminated
Initiated: 2006-05-05
Posted: 2006-10-28
Terminated: 2006-11-02
Recalling firm: Medtronic, Inc. (Minneapolis, MN 55447)
Product: 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.
Product code: GEH Unit, Cryosurgical, Accessories
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Lot: 50515, 50602, 50609

Product code GEH

K053436Class IISurgifrost 6Cm, 7Cm and 10 Cm Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. / cleared 2006-01-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)