Recall Z-3095-2024 ยท NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
MEDLINE INDUSTRIES, LP - Northfield
Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R.
| Date | Sep 10, 2024 (initiated May 7, 2024) |
| Status | Open, Classified |
| Reason | Potential for an incomplete seal on the packaging tray. |
| Root cause | Under Investigation by firm |
| Action | Medline notified consignees on about 05/06/2024 via letter sent email or First-Class mail. Consignees were instructed to examine inventory and quarantine any affected units, return any affected product that they may have on hand for credit or replacement, notify customers or personnel if the affected product was further distributed or transferred, and complete and return the response form. |
| Quantity | 46 units |
| Distribution | US Nationwide distribution. |
| 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 |