—#209516

Product

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.

FDA product code: NLQ — Single-Use Reprocessed Ultrasonic Surgical Instruments
Device class: Class U
Medical specialty: Unknown
510(k) numbers: K193563
Affected lot / code info: Item Number: HARH36R. UDI/DI: 20193489081326 (case), 10193489081329 (each). Lot Numbers: 499617, 499843, 500207, 500315, 507265.

Why it was recalled

Potential for an incomplete seal on the packaging tray.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2024-05-07
Posted by FDA: 2024-09-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209516. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.