Home / Recalls / Sharp Medical Products / Z-1366-2021

Z-1366-2021 Class II Terminated

Recalled by Sharp Medical Products — Scottsdale, AZ

Recall Details

Product Type
Devices
Report Date
April 14, 2021
Initiation Date
February 8, 2021
Termination Date
February 17, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
129 units (63 units for Human-use and 66 units for Non-Human use)

Product Description

SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult

Reason for Recall

Non-conformity (holes/punctures or deep creases) in the sterile barrier.

Distribution Pattern

U.S.: AZ, FL, MI, OH, TX, and WI. O.U.S.: None

Code Information

Catalogue Number: 100-36-01 Lot Number: 0818-009