Recall Z-1366-2021— Sharp Medical Products
Class II · Terminated
Class II FDA medical device recall by Sharp Medical Products, initiated 2021-02-08, terminated 2023-02-17. It names one FDA 510(k) clearance: K150549. Product: SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult. Reason: Non-conformity (holes/punctures or deep creases) in the sterile barrier..
- Recalling firm
- Sharp Medical Products
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-02-08
- Terminated
- 2023-02-17
- Firm location
- Scottsdale, AZ, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.