Z-1815-2010

CaviBleach Wipes; a disinfectant medical device, active ingredient Sodium hypochlorite 0.525%; a single 9" x...

Name: Z-1815-2010 CaviBleach Wipes; a disinfectant medical device, active ingredient Sodium hypochlorite 0.525%; a single 9" x...
Creator: Medtrol, Inc.
Published: 2009-12-02
License: https://open.fda.gov/license/

Medtrol, Inc. / initiated 2009-12-02 / Terminated / root cause: manufacturing process

FDA source

Medtrol, Inc. began a recall of 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%... on 2009-12-02. The reason FDA records is "The disinfectant wipes were found out of specifications for the disinfectant activity prior to the expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1815-2010
Status: Terminated
Initiated: 2009-12-02
Posted: 2010-06-22
Terminated: 2010-06-23
Recalling firm: Medtrol, Inc.
Product: 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-porous surfaces, patient care equipment and point of care equipment.
Product code: LRJ Disinfectant, Medical Devices
Reason for recall: The disinfectant wipes were found out of specifications for the disinfectant activity prior to the expiration date.
Root cause tag: manufacturing process
FDA 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 information, contact Metrex Customer Care Center at 1-800-841-1428.
Quantity in commerce: 150 cases
Distribution: Nationwide Distribution -- Including state of Michigan.
Product codes and lots: Reorder No. 10-1155, LotF29, Exp June 2010

Product code LRJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)