Recall Z-0120-2024
MEDLINE INDUSTRIES, LP - Northfield · initiated August 3, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.
Codes / lots: UDI/DI 10193489081336 (each), 20193489081333 (case), Lot Numbers: 498739, 498740, 499057, 499143, 499227
Reason for recall
Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
FDA-determined cause: Packaging
Action taken
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.
Details
- Recall number
- Z-0120-2024
- Initiated
- August 3, 2023
- Posted by FDA
- October 16, 2023
- Product code
- NLQ – Single-Use Reprocessed Ultrasonic Surgical Instruments
- Quantity
- 18 units
- Distribution
- US
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0117-2024 Class II | MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10…Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the… | 08/03/2023Open, Classified |
| Z-0118-2024 Class II | MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10…Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the… | 08/03/2023Open, Classified |
| Z-0119-2024 Class II | MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF…Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the… | 08/03/2023Open, Classified |