Z-0753-2017 Class III Terminated

Recalled by Ecolab Inc — Saint Paul, MN

FDA device recall Z-0753-2017 was initiated by Ecolab Inc on November 30, 2016 and is designated Class III. 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 shippe… The recall status is terminated (terminated August 21, 2019). Affected quantity: 40 cases (144 eaches per box).

Recall Details

Product Type
Devices
Report Date
December 21, 2016
Initiation Date
November 30, 2016
Termination Date
August 21, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
40 cases (144 eaches per box)

Product Description

Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.

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.

Distribution Pattern

US Distribution to the states of : CA, FL, MI, NJ, TX, UT and VA..

Code Information

15302