Z-0753-2017Class III

Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only

Name: Z-0753-2017 Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only
Creator: Ecolab Inc
Published: 2016-11-30
License: https://open.fda.gov/license/

Microtek Medical LLC / initiated 2016-11-30 / Terminated / root cause: labeling and UDI

FDA source

Ecolab Inc began a recall of Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only on 2016-11-30. FDA classified it as Class III and gives the reason as "The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the incorrect expiration date (2015-10-01) on the label while the individual pouch labels and outer shipper have the correct...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0753-2017
Classification: Class III
Status: Terminated
Initiated: 2016-11-30
Posted: 2016-12-14
Terminated: 2019-08-21
Recalling firm: Microtek Medical LLC
Product: Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.
Product code: KKX Drape, Surgical, Antimicrobial
Reason for recall: The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the incorrect expiration date (2015-10-01) on the label while the individual pouch labels and outer shipper have the correct expiration date (2018-10-01). The manufacturing date was inadvertently used as the expiration date on the inner carton box labels.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: Ecolab sent an "Urgent Medical Device Recall" letter dated November 30, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised to quarantine the product for return. If the product was further distributed notify them of the recall. Requested customers to complete and return the Recall Response Form. For questions contact Customer Service by phone at 1-800-824-3027 or e-mail [email protected]. For further questions please call (651) 250-4385.
Quantity in commerce: 40 cases (144 eaches per box)
Distribution: US Distribution to the states of : CA, FL, MI, NJ, TX, UT and VA..
Product codes and lots: 15302

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0753-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0753-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-14

Product code KKX

K882724Class IIMicrotek Probe DrapeMicrobio-Medics, Inc. / cleared 1988-08-03

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)