Z-0615-2011

Incorrect Label: Endocare 2.4mm VARIABLE ATTACHED CRYOPROBE, REF: CVA 2400, LOT 2751. Correct Label: Endocare...

Name: Z-0615-2011 Incorrect Label: Endocare 2.4mm VARIABLE ATTACHED CRYOPROBE, REF: CVA 2400, LOT 2751. Correct Label: Endocare...
Creator: Endocare, Division Of Healthtronics
Published: 2010-11-04
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2010-11-04 / Terminated / root cause: labeling and UDI

FDA source

Endocare, Division Of Healthtronics began a recall of Incorrect Label: Endocare 2.4mm VARIABLE ATTACHED CRYOPROBE, REF: CVA 2400, LOT 2751. Correct Label: Endocare 2.4mm CRYOPROBE, REF: CRYO-44F (Sharp Tip) on 2010-11-04. The reason FDA records is "Mislabeled : The label on the outer box and inner pouch of the EndoCare 2.4mm CryoProbe (CRYO-44F) inaccurately reference the CVA2400 (2.4mm Variable Probe aka: V-Probe)". 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-0615-2011
Status: Terminated
Initiated: 2010-11-04
Posted: 2010-12-13
Terminated: 2011-04-14
Recalling firm: Varian Medical Systems, Inc.
Product: Incorrect Label: Endocare 2.4mm VARIABLE ATTACHED CRYOPROBE, REF: CVA 2400, LOT 2751. Correct Label: Endocare 2.4mm CRYOPROBE, REF: CRYO-44F (Sharp Tip).
Product code: GEH Unit, Cryosurgical, Accessories
Reason for recall: Mislabeled : The label on the outer box and inner pouch of the EndoCare 2.4mm CryoProbe (CRYO-44F) inaccurately reference the CVA2400 (2.4mm Variable Probe aka: V-Probe).
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Healthronics issued an Urgent Device Recall letter dated November 2, 2010 to consignees. The letter described the product mislabeling, and requested customers to examine their inventory, quarantine all affected product, and complete and return the verfication section of the letter to the firm. A return authorization number and prepaid return label were provide to facilitate return and replacement. Healthronics can be contacted at 877 367-4873 concerning this recall.
Quantity in commerce: 33 Units
Distribution: Nationwide Distribution: to the states of FL, MI, PA, TN, and WA.
Product codes and lots: Part #CRYO-44F. Lot 2751. 510(K): K060279. Product Code: GEH.

Product code GEH

K060279Class IICryocare Cs Surgical SystemEndocare, Inc. / cleared 2006-02-28

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)