FDA-Device2026-10-21Class IIPROCESSING DEFECT
Medline CABG Auxiliary Pack surgical kits recalled for cannula component defects
What this means
Medline distributed surgical convenience kits containing cannula components that do not meet required dimensional standards. These defects may cause the cannula to leak or break during use.
- Check if you have a Medline CABG Auxiliary Pack (Product Number DYNJ44925D) with one of the affected lot numbers listed in the recall notice.
- Do not use affected kits; contact Medline or your supplier for replacement or guidance.
- Report any issues or injuries to Medline or the FDA.
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
3125 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925D
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0168-2027More Medline recalls
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