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).
Reported: July 11, 2018 Initiated: November 22, 2017 #Z-2332-2018
Product Description
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).
Reason for Recall
The incorrect IFU was shipped with the product.
Details
- Recalling Firm
- ECOLAB INC
- Units Affected
- 65 cases
- Distribution
- US Distribution to the states of : CA, IL, LA, SC, TX, and WI. There was no foreign/government/military distribution.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by ECOLAB INC. Units affected: 65 cases.
Why was this product recalled? ▼
The incorrect IFU was shipped with the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 11, 2018. Severity: Low. Recall number: Z-2332-2018.
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