Reprocessed Surgical Sealer/Divider Recalled for Potential Packaging Seal Defect
Medline Industries is recalling the ReNewal Reprocessed Covidien LigaSure Impact Sealer/Divider due to a potential incomplete seal on the packaging tray. The recall affects 230 units nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a precautionary packaging seal defect with no reported illnesses, injuries, or deaths. The recall addresses a potential sterilization barrier compromise.
Plain-English summary
Medline Industries, LP is recalling the ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated (Item Number: LF4418CR). This is a reprocessed surgical instrument designed for use with compatible FT10 devices running software version 4.0.1.15 or lower.
The recall was initiated due to a potential for an incomplete seal on the packaging tray. This could compromise the sterilization barrier of the device.
The recall affects 230 units distributed nationwide in the United States. The affected lot numbers are: 500376, 500379, 500380, 500381, 500382, 500504, 500506, 500548, 500559, 500652, 500695, 500874, 503004, and 503289.
The recalled product
- Product
- Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF4418CR.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- packaging-seal-defect
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 (15)
- Item Number: LF4418CR. UDI/DI: 20888277680446 (case)
- 10888277680449 (each). Lot Numbers: 500376
- 500379
- 500380
- 500381
- 500382
- 500504
- 500506
- 500548
- 500559
- 500652
- 500695
- 500874
- 503004
- 503289.
Distribution
Distributed nationwide across the United States.
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