Sharp Medical Products recall: Sterility Concern
SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
Why was Sharp Medical Products recalled?
Non-conformity (holes/punctures or deep creases) in the sterile barrier.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalogue Number: 100-36-01 Lot Number: 0818-009
- Product
- SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
- Recalling firm
- Sharp Medical Products
- Quantity
- 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
- Recall date
- April 14, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)