Z-1366-2021 Class II Terminated
FDA device recall Z-1366-2021 was initiated by Sharp Medical Products on February 8, 2021 and is designated Class II. Reason for recall: Non-conformity (holes/punctures or deep creases) in the sterile barrier. The recall status is terminated (terminated February 17, 2023). Affected quantity: 129 units (63 units for Human-use and 66 units for Non-Human use).
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