Recall Z-1907-2021— Exact Medical Manufacturing, Inc.

Name: FDA recall Z-1907-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-29

Class II · Terminated

Class II FDA medical device recall by Exact Medical Manufacturing, Inc., initiated 2021-04-29, terminated 2022-05-26. It names one FDA 510(k) clearance: K101689. Product: Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA. Reason: No 510k for the product to be used in a natural or surgical opening to the body.

Recalling firm: Exact Medical Manufacturing, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-04-29
Terminated: 2022-05-26
Firm location: Lancaster, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K101689 — EMM EQUIPMENT COVER-POLYTHYLENEExact Medical Manufacturing, Inc.·cleared 2010-09-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.