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 transducer (probe).
This recall has been terminated (originally issued November 22, 2017).
- Company
- Ecolab Inc
- Recall Initiated
- November 22, 2017
- Terminated
- July 22, 2020
- Recall Number
- Z-2332-2018
- Quantity
- 65 cases
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
The incorrect IFU was shipped with the product.
Distribution
US Distribution to the states of : CA, IL, LA, SC, TX, and WI. There was no foreign/government/military distribution.
Lot / Code Info
Lot numbers D151871, D151961, D161861, D162001, and D162911
Root Cause
Labeling False and Misleading
Action Taken
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 further questions, please call (651) 250-4385.