FDA-Device2026-02-04Class IIPACKAGING DEFECT
Medline medical procedure kits recalled for defective MASTISOL adhesive tubing
Stop using affected Medline procedure kits
Medline distributed eight types of medical procedure convenience kits containing MASTISOL liquid adhesive. The adhesive vials had cracked butyrate tubing that could break when the vial is opened, potentially affecting the sterility or usability of the kit.
- Check if you have any of the eight affected Medline kit SKUs (DYNJ0972604A, DYNJ33822L, DYNJ45640B, DYNJ63377D, DYNJ65011D, DYNJ69143C, DYNJ69313, or DYNJ86007B)
- Do not use affected kits; contact your Medline supplier or the FDA for instructions on return or replacement
- Verify lot numbers match the recalled batches before using any kit in stock
Hazard
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Who it affects
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
1,928 total
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMAKER/ICD PACK, Kit SKU DYNJ33822L; 3) VENOUS ACCESS PACK, Kit SKU DYNJ45640B; 4) PACEMAKER SET UP, Kit SKU DYNJ63377D; 5) PACK PACEMAKER CUSTOM,9909178, Kit SKU DYNJ65011D; 6) HEART BASIC OPEN PACK, Kit SKU DYNJ69143C; 7) SCC VEIN PACK, Kit SKU DYNJ69313; 8) CV PACK, Kit SKU DYNJ86007B.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1188-2026More Medline recalls
- FDA-PR2026-08-05Medline Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits recalled for connector overheating risk
- FDA-Device2026-07-29Medline surgical convenience kits recalled for quality issues in anesthetic component
- FDA-Device2026-07-29Medline NEURO PACK medical kits recalled for Bacillus contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
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