Recall Z-0615-2011 ยท GEH Unit, Cryosurgical, Accessories
Endocare, Division Of Healthtronics
Incorrect Label: Endocare 2.4mm VARIABLE ATTACHED CRYOPROBE, REF: CVA 2400, LOT 2751. Correct Label: Endocare 2.4mm CRYOPROBE, REF: CRYO-44F (Sharp Tip).
| Date | Dec 13, 2010 (initiated Nov 4, 2010) |
| Status | Terminated |
| Reason | 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 | 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 | 33 Units |
| Distribution | Nationwide Distribution: to the states of FL, MI, PA, TN, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060279 | CRYOCARE CS SURGICAL SYSTEM Endocare, Inc., Feb 28, 2006 |