MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF1844CR. electrosurgi
FDA device recall Z-0117-2024 · posted 2023-10-16 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
- 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.
- Root cause
- Packaging
- Status
- Open, Classified
- Product code
- NUJ
- Quantity affected
- 11 units
- Distribution
- US
- Date initiated
- 2023-08-03
- Date posted
- 2023-10-16
- Location
- Northfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider (K160333) | Surgical Instrument Service and Savings, Inc. | 2016-07-20 |