Recall Z-1366-2021 ยท GCJ Laparoscope, General & Plastic Surgery
Sharp Medical Products
SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
| Date | Feb 8, 2021 |
| Status | Terminated |
| Reason | Non-conformity (holes/punctures or deep creases) in the sterile barrier. |
| Root cause | Under Investigation by firm |
| Action | On 02/08/2021 the firm began notifying customers and received confirmation that affected lot was still on customers shelves. On 03/03/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification Letter via certified US mail informing customers that they have become aware of product that either have holes or deep creases in the sterile barrier that makes the product unsafe for use and could lead to patient infection, sepsis, or death if used. Customer are instructed: 1.That any/all remaining units on their shelves should be disposed of in the trash. 2. Complete "MEDICAL DEVICE RECALL R |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150549 | Reactor(TM) Trocar and Sleeve Sharp Medical Prducts, LLC, Jun 1, 2015 |