FDA-Device2026-10-21Class IIPROCESSING DEFECT
Medline open heart surgical kits recalled for cannula defects causing leaks or breaks
What this means
Medline distributed 165 open heart surgical convenience kits (SKU DYNJ902898D) with cannula components that don't meet required safety dimensions. The defective cannulas may leak or break during use, which could compromise patient safety during surgery.
- If your facility received these kits (lot numbers 23GBD734 or 23EBQ512), stop using them immediately.
- Check the UDI-DI numbers 10195327369743 or 40195327369744 to confirm if your kits are affected.
- Contact Medline customer service for replacement kits or return instructions.
- Review patient records if any of these kits were already used during procedures.
The agency's original wording
Hazard
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
165 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0178-2027More Medline recalls
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