Recall Z-0120-2024 ยท NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.
| Date | Oct 16, 2023 (initiated Aug 3, 2023) |
| Status | Open, Classified |
| Reason | Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray. |
| Root cause | Packaging |
| Action | Medline issued a recall notice to its consignees by email on 08/03/2023. The notice explained the problem and the potential risk. Those consignees who have transferred possession of the affected product were directed to notify their customers. The firm is seeking the return of the affected product. An error in the model number was noted (missing an "R" at the end) and the firm issued an updated letter on 09/19/2023 with the corrected number. |
| Quantity | 18 units |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193563 | Medline ReNewal Reprocessed Harmonic ACE+7 Shears Surgical Instrument Service and Savings Inc.(Dba Medline Ren, Aug 19, 2020 |