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Terminated

Hays Ultrasound kit Item ID: H1000SE

FDA Recall Z-1918-2021 · Posted None

Recalling FirmExact Medical Manufacturing, Inc.
Recall StatusTerminated
Product CodeITX
Date Initiated2021-04-29
Date Terminated2022-05-26
Product Quantity10020 units

Reason for Recall

No 510k for the product to be used in a natural or surgical opening to the body

Firm Action

Exact Medical issued Correction Notification via email on 4/29/21. Letter states: Exact Medical Manufacturing Ultrasonic Transducer Cover can be used to minimize contamination between patient and ultrasound probe during ultrasound scanning procedures for external intact skin. This may help with easier cleaning and disinfection of the probe. This product is not to be used in a natural or surgical opening to the body. The Exact Medical Manufacturing Ultrasonic Transducer Cover are also sold as bulk non-sterile, single use items, to repackers/relabelers establishments for further packaging and ethylene oxide sterilization. These are the boundaries and limitations of use for existing Probe/Transducer cover products in any existing stock from Exact Medical Manufacturing, Inc Further instructions will be given at a future date and we encourage you to reach out with any questions or concerns regarding this issue.

Root Cause

No Marketing Application

Distribution Pattern

US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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