FDA Recall Terminated

Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.

Recall: Z-0753-2017 · Initiated November 30, 2016

Recall

Recall Number
Z-0753-2017
Event Number
75826
Firm
Ecolab Inc
FEI Number
1000289767
Product Code
KKX
Status
Terminated
Root Cause
Incorrect or no expiration date
Initiated
November 30, 2016
Terminated
August 21, 2019
Address
370 Wabasha St N, Saint Paul, MN, 55102-1323

Description

Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.

Reason

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.

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.

Distribution

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

Quantity

40 cases (144 eaches per box)