Reported Apr 14, 2021 · Terminated
SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
Sharp Medical Products
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sharp Medical Products · 14362 N Frank Lloyd Wright Blvd · Scottsdale, AZ · 85260-8846
Is this the product you have?
- SHARP MEDICAL PRODUCTS, LLC
- Reactor and Sleeve REF 100-36-01 SizeAdult
- Lot codes and dates
- Catalogue Number100-36-01
- Lot Number0818-009
- Amount recalled
- 129 units (63 units for Human-use and 66 units for Non-Human use)
Where it was sold
Why it was recalled
Non-conformity (holes/punctures or deep creases) in the sterile barrier.
This product could cause temporary or reversible health problems — stop using it.
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