—#202915

Product

MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.

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: UDI/DI 10193489081336 (each), 20193489081333 (case), Lot Numbers: 498739, 498740, 499057, 499143, 499227

Why it was recalled

Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.

Root cause (FDA determination)

Packaging

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: US

Timeline

Recall initiated: 2023-08-03
Posted by FDA: 2023-10-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #202915. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.