SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
Reported: April 14, 2021 Initiated: February 8, 2021 #Z-1366-2021
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.
Details
- Recalling Firm
- Sharp Medical Products
- Units Affected
- 129 units (63 units for Human-use and 66 units for Non-Human use)
- Distribution
- U.S.: AZ, FL, MI, OH, TX, and WI. O.U.S.: None
- Location
- Scottsdale, AZ
Frequently Asked Questions
What product was recalled? ▼
SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult. Recalled by Sharp Medical Products. Units affected: 129 units (63 units for Human-use and 66 units for Non-Human use).
Why was this product recalled? ▼
Non-conformity (holes/punctures or deep creases) in the sterile barrier.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 14, 2021. Severity: Moderate. Recall number: Z-1366-2021.
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