Incorrect Label: Endocare 2.4mm VARIABLE ATTACHED CRYOPROBE, REF: CVA 2400, LOT 2751. Correct Label: Endocare 2.4mm CRYOPROBE, REF: CRYO-44F (Sharp Tip).
This recall has been terminated (originally issued December 13, 2010).
- Recall Initiated
- November 4, 2010
- Posted
- December 13, 2010
- Terminated
- April 14, 2011
- Recall Number
- Z-0615-2011
- Quantity
- 33 Units
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
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).
Distribution
Nationwide Distribution: to the states of FL, MI, PA, TN, and WA.
Lot / Code Info
Part #CRYO-44F. Lot 2751. 510(K): K060279. Product Code: GEH.
Root Cause
Other
Action Taken
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.