FDA recall Z-1366-2021
Sharp Medical Products · Class II · device
Product
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
U.S.: AZ, FL, MI, OH, TX, and WI. O.U.S.: None
Key facts
- Status
- Terminated
- Initiation date
- 2021-02-08
- Report date
- 2021-04-14
- Termination date
- 2023-02-17
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Scottsdale, AZ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1366-2021