ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe c...

FDA Device Recall #Z-2332-2018 — Class III — November 22, 2017

Recall Summary

Recall Number Z-2332-2018
Classification Class III — Low risk
Date Initiated November 22, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm ECOLAB INC
Location Saint Paul, MN
Product Type Devices
Quantity 65 cases

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.

Distribution Pattern

US Distribution to the states of : CA, IL, LA, SC, TX, and WI. There was no foreign/government/military distribution.

Lot / Code Information

Lot numbers D151871, D151961, D161861, D162001, and D162911

Other Recalls from ECOLAB INC

Recall # Classification Product Date
Z-1141-2021 Class II Slush + Warmer Disc Drape; Model ORS-320 Slush ... Jan 11, 2021
Z-0233-2019 Class II Disposable Accessory Kit, 3-Arm (Box of 5) indi... Sep 14, 2018
Z-0231-2019 Class II Instrument Arm Drape (Box of 20) individually s... Sep 14, 2018
Z-0232-2019 Class II Camera Arm Drape (Box of 20) individually seale... Sep 14, 2018
Z-0234-2019 Class II Disposable Accessory Kit, 4-Arm (Box of 5) indi... Sep 14, 2018

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.