Medline ReNewal Reprocessed LigaSure Blunt Tip Recalled for Packaging Seal Defect
Medline Industries is recalling 3,618 units of ReNewal Reprocessed Covidien LigaSure Blunt Tip surgical devices due to potential incomplete seals on packaging trays. The seal defect could compromise product sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a surgical device with potential incomplete packaging seals. No injuries or illnesses have been reported; the hazard is theoretical but represents a significant risk for surgical safety.
Plain-English summary
Medline Industries, LP is recalling 3,618 units of the ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated surgical device (Item Number: LF1837CR). The affected units were distributed nationwide in the United States. The FDA has classified this recall as Class II.
The recall was issued because of a potential for incomplete seals on the packaging trays. An incomplete seal could compromise the sterility of the device, creating a risk during surgical use.
Healthcare facilities and surgical centers should verify whether they have devices with the affected lot numbers. Consumers and healthcare providers should refer to the FDA recall notice at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-3092-2024 for the complete list of affected lot numbers and further instructions.
The recalled product
- Product
- Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1837CR.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- seal-defect
- sterility-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Item Number: LF1837CR. UDI/DI: 20888277680392 (case)
- 10888277680395 (each). Lot Numbers: 487233
- 487315
- 487475
- 487511
- 499861
- 499917
- 500068
- 500138
- 500201
- 500290
- 500341
- 500500
- 500502
- 500522
- 500524
- 500610
- 500614
- 500656
- 500657
Distribution
Distributed nationwide across the United States.
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