Recall Z-1815-2010 ยท LRJ Disinfectant, Medical Devices
Medtrol, Inc.
CaviBleach Wipes; a disinfectant medical device, active ingredient Sodium hypochlorite 0.525%; a single 9" x 9" towelette, pre-moistened with 0.525% - 0.656% sodium hypochlorite, packaged in a flexible poly foil pouch, 50 wipes per dispenser box, 8 boxes per case; Manufactured for Metrex Research Corporation, 28210 Wick Road, Romulus, MI 48174. General purpose disinfectant wipe for hard, non-poro
| Date | Jun 22, 2010 (initiated Dec 2, 2009) |
| Status | Terminated |
| Reason | The disinfectant wipes were found out of specifications for the disinfectant activity prior to the expiration date. |
| Root cause | Process control |
| Action | Medtrol telephoned Metrex on December 2, 2009, informing them that Medtrol was requesting the recall of the affected product. Metrex sent Urgent Medical Device Recall letters dated December 3, 2009 to their accounts, requesting them to examine their inventory for the affected product, and return any found for credit. They also requested their accounts to sub-recall the product to the retail level. Metrex also requested their accounts to complete and return the enclosed reply sheet, acknowledging receipt of the recall letter and indicating the amount of product being returned. For further |
| Quantity | 150 cases |
| Distribution | Nationwide Distribution -- Including state of Michigan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.