FDAFDA · Food and drugs·Recall number Z-1366-2021
SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
Published April 14, 2021 · Recall initiated: February 8, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Non-conformity (holes/punctures or deep creases) in the sterile barrier.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Sharp Medical Products
- Distributor
- U.S.: AZ, FL, MI, OH, TX, and WI. O.U.S.: None
- Lot
- Catalogue Number: 100-36-01 Lot Number: 0818-009
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.