Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.
FDA Recall Z-0753-2017 · Posted None
Recalling FirmEcolab Inc
Recall StatusTerminated
Product CodeKKX
Date Initiated2016-11-30
Date Terminated2019-08-21
Product Quantity40 cases (144 eaches per box)
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.
Firm 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.
Root Cause
Incorrect or no expiration date
Distribution Pattern
US Distribution to the states of : CA, FL, MI, NJ, TX, UT and VA..
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.