Recall Z-0753-2017 ยท KKX Drape, Surgical, Antimicrobial
Ecolab Inc
Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only.
| Date | Nov 30, 2016 |
| Status | Terminated |
| 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. |
| 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 customerservice@microtekmed.com. For further questions please call (651) 250-4385. |
| Quantity | 40 cases (144 eaches per box) |
| Distribution | US Distribution to the states of : CA, FL, MI, NJ, TX, UT and VA.. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K882724 | MICROTEK PROBE DRAPE Microbio-Medics, Inc., Aug 3, 1988 |