Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Versi
FDA device recall Z-3094-2024 · posted 2024-09-10 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- Potential for an incomplete seal on the packaging tray.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- NUJ
- Quantity affected
- 230 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2024-05-07
- Date posted
- 2024-09-10
- Location
- Northfield, IL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider (K153745) | Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2016-05-02 |