Recall Z-2332-2018 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
ECOLAB INC
ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluids, gels) and/or to maintain the required hygienic level of various diagnostic or surgical procedures which utilize a tran
| Date | Nov 22, 2017 |
| Status | Terminated |
| Reason | The incorrect IFU was shipped with the product. |
| Root cause | Labeling False and Misleading |
| Action | The recalling firm issued letters dated November 21, 2017, informing the customer the incorrect IFU was shipped with the product and a correct version of the IFU is being provided with the letter. The consignee was requested to notify downstream customers to the user level and that a copy of the letter could be forwarded to enhance communication. A Recall Response Form was enclosed for completion to be returned via FAX or email as soon as possible. The letter also informs the consignee that the recalling firm will send additional replacement IFU's if they have product in inventory. For fur |
| Quantity | 65 cases |
| Distribution | US Distribution to the states of : CA, IL, LA, SC, TX, and WI. There was no foreign/government/military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961029 | KILTEX PROBE COVER Kiltex Corp., Jul 25, 1996 |