FDA Recall
Open, Classified
MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.
Recall: Z-0120-2024
·
Initiated August 3, 2023
Recall
- Recall Number
- Z-0120-2024
- Event Number
- 92920
- Firm
- MEDLINE INDUSTRIES, LP Northfield
- FEI Number
- 1417592
- Product Code
- NLQ
- Status
- Open, Classified
- Root Cause
- Packaging
- Initiated
- August 3, 2023
- Posted
- October 16, 2023
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753
Description
MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.
Reason
Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
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.
Distribution
US
Quantity
18 units