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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1366-2021 |
| Event ID | 87432 |
| Event Description | SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult |
| Product Type | Devices |
| Distribution | U.S.: AZ, FL, MI, OH, TX, and WI. O.U.S.: None |
| Quantity | 129 units (63 units for Human-use and 66 units for Non-Human use) |
| Recall Reason | Non-conformity (holes/punctures or deep creases) in the sterile barrier. |
| Device Classification | 20210414 |
| Device Code Info | Catalogue Number: 100-36-01 Lot Number: 0818-009 |
| Center Classification Date | 20210406 |
| Recall Initiation Date | 20210208 |
| Recalling Firm | Sharp Medical Products |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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