Medline C-Section Surgical Kits Recalled Over Sterilization Calibration
Medline is recalling 4,525 C-section convenience kits worldwide due to calibration issues with sterilization and packaging equipment that could affect sterility assurance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall with risk-of-harm to sterility assurance level; no reported injuries or illnesses, which limits the score to High per rubric criteria.
Plain-English summary
Medline Industries, LP is recalling 4,525 units of its C-section convenience kits distributed worldwide, including nationwide in the U.S. The recall includes multiple models such as C-SECTION PACK, C-SECTION TRAY, and LUD C-SECTION-LF, each identified by specific model numbers and lot numbers.
The recall is due to calibration issues with the equipment used to sterilize and package the devices. While all products were exposed to validated sterilization and packaging cycles, the calibration problems have the potential to impact the sterility assurance level (SAL) of the recalled products.
Healthcare facilities and providers that received the affected kits should review the lot numbers provided in the recall notice and remove any affected units from inventory. No illnesses or injuries have been reported in connection with this recall.
The recall affects products distributed worldwide. Facilities should contact Medline for instructions on returning or replacing affected units.
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 — Surgical Kits
- Affected units
- 4,525
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.
Part of a larger recall action
This product is one of 42 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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