Home / Recalls / Exact Medical Manufacturing, Inc. / Z-1918-2021

Z-1918-2021 Class II Terminated

Recalled by Exact Medical Manufacturing, Inc. — Lancaster, NY

Recall Details

Product Type
Devices
Report Date
June 30, 2021
Initiation Date
April 29, 2021
Termination Date
May 26, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10020 units

Product Description

Hays Ultrasound kit Item ID: H1000SE

Reason for Recall

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

Distribution Pattern

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

Code Information

Lot Numbers: 2005E090 2006E495

Other recalls by Exact Medical Manufacturing, Inc.

  • Z-1921-2021 Class II — Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22 (April 29, 2021)
  • Z-1908-2021 Class II — Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover (April 29, 2021)
  • Z-1915-2021 Class II — Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359 (April 29, 2021)
  • Z-1922-2021 Class II — Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29 (April 29, 2021)
  • Z-1920-2021 Class II — Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17 (April 29, 2021)
  • Z-1917-2021 Class II — Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Ite (April 29, 2021)
  • Z-1913-2021 Class II — Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item (April 29, 2021)
  • Z-1919-2021 Class II — Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item (April 29, 2021)
  • Z-1909-2021 Class II — 6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852N (April 29, 2021)
  • Z-1914-2021 Class II — Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E532 (April 29, 2021)