FDA-Device2026-10-21Class IIPROCESSING DEFECT
Medline CV Basin Pack surgical kits recalled for cannula component defect risk
What this means
Medline surgical convenience kits (CV BASIN PACK-LF) contain cannula components that do not meet required dimensional standards. These defective components may leak or break during medical use.
- Check if you have affected kits using product numbers DYNJ0538615K, DYNJ0538615J, or DYNJ0538615L
- Do not use kits with the affected lot numbers listed in the recall notice
- Contact Medline or your healthcare facility for instructions on replacement or return
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
235 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF, Medline Product number/SKU DYNJ0538615K; 2) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615J; 3) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615L.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0175-2027More Medline recalls
- FDA-Device2026-10-22Medline medical convenience kits recalled for difficult removal and adhesive residue
- FDA-Device2026-10-22Medline sterile C-section surgical drape recalled for difficult removal and skin adhesive residue
- FDA-Device2026-10-22Medline medical convenience kits recalled for difficult removal and adhesive residue
- FDA-Device2026-10-22Medline surgical convenience kits recalled for difficult removal and adhesive residue
- FDA-Device2026-10-22Medline tubal ligation surgical kit recalled for difficult removal and skin adhesive residue
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