Incorrect Label: Endocare 2.4mm VARIABLE ATTACHED CRYOPROBE, REF: CVA 2400, LOT 2751. Correct Label: Endocare 2.4mm CRYOPROBE, REF: CRYO-44F (Sharp Tip).
FDA Recall Z-0615-2011 · Posted 2010-12-13
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Recalling FirmEndocare, Division Of Healthtronics
Recall StatusTerminated
Product CodeGEH
Date Initiated2010-11-04
Date Terminated2011-04-14
Product Quantity33 Units
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).
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide Distribution: to the states of FL, MI, PA, TN, and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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