Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Nu
Pending LLM rewrite. Source: FDA_DEVICE Z-1417-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
The recalled product
- Product
- Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
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)
- 1) CDS820080N
- UDI-DI: 10195327278014(each)
- 40195327278015(case)
- Lot Number: 23IMB818
- 2) CDS983523G
- UDI-DI: 10195327283681(each)
- 40195327283682(case)
- Lot Number: 23IBS984
- 3) CDSCCR611O
- UDI-DI: 10193489367904(each)
- 40193489367905(case)
- Lot Number: 21WBA953
- 4) CDSCCR611O
- Lot Number: 21LBC555
- 5) CDSCCR611O
- Lot Number: 21CBN328
- 6) CDSCCR611P
- UDI-DI: 10195327065850(each)
- 40195327065851(case)
- Lot Number: 22IBG757
Distribution
Distributed nationwide across the United States.
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