FDA-Device2026-02-04Class IIPACKAGING DEFECT
Medline medical procedure kits recalled for defective adhesive applicator tubing
Check Medline procedure kits for cracked adhesive applicators
Medline medical procedure convenience kits containing MASTISOL liquid adhesive were distributed with a manufacturing defect. The butyrate tubing in the adhesive applicator vials can crack when used, potentially affecting the adhesive's delivery or safety during medical procedures.
- Check if you have Medline kit SKU DT22880 (Lot 25KMJ441) or SKU DYNDC3283A (Lot 25KMH515)
- Do not use the MASTISOL adhesive if the tubing is cracked or damaged
- Contact your Medline supplier or the manufacturer for replacement or guidance
- If you already used a kit from these lots, monitor the application site for any issues
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) INPATIENT CTRL LN DRG CHG, Kit SKU DT22880; 2) ADULT CVC DRSG CHG W/ADHESIVE, Kit SKU DYNDC3283A.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1195-2026More Medline recalls
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