Product Safety Recalls

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Sharp Medical Products Recall 87432

Description: SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult

Sharp Medical Products Recall 87432 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1366-2021
Event ID87432
Event DescriptionSHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
Product TypeDevices
DistributionU.S.: AZ, FL, MI, OH, TX, and WI. O.U.S.: None
Quantity129 units (63 units for Human-use and 66 units for Non-Human use)
Recall ReasonNon-conformity (holes/punctures or deep creases) in the sterile barrier.
Device Classification20210414
Device Code InfoCatalogue Number: 100-36-01 Lot Number: 0818-009
Center Classification Date20210406
Recall Initiation Date20210208
Recalling FirmSharp Medical Products
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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