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U.S. Department of Health and Human Services

Class 2 Device Recall Endocare 2.4mm VARIABLE ATTACHED CRYOPROBE

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 Class 2 Device Recall Endocare 2.4mm VARIABLE ATTACHED CRYOPROBEsee related information
Date Initiated by FirmNovember 04, 2010
Date PostedDecember 13, 2010
Recall Status1 Terminated 3 on April 14, 2011
Recall NumberZ-0615-2011
Recall Event ID 57214
510(K)NumberK060279 
Product Classification Unit, cryosurgical, accessories - Product Code GEH
ProductIncorrect Label: Endocare 2.4mm VARIABLE ATTACHED CRYOPROBE, REF: CVA 2400, LOT 2751. Correct Label: Endocare 2.4mm CRYOPROBE, REF: CRYO-44F (Sharp Tip).
Code Information Part #CRYO-44F. Lot 2751. 510(K): K060279. Product Code: GEH.
FEI Number 3008262715
Recalling Firm/
Manufacturer		 Endocare, Division Of Healthtronics
9825 Spectrum Dr Bldg 2 #275
Austin TX 78717
Manufacturer 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).
FDA Determined
Cause 2		Other
ActionHealthronics 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 Commerce33 Units
DistributionNationwide Distribution: to the states of FL, MI, PA, TN, and WA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GEH
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