FDA-Device2026-02-04Class IIPROCESSING DEFECT

Medline medical procedure kits recalled for defective adhesive tubing

OTHERNationwide distributionMedical devices

What this means

Medline distributed nine types of medical procedure convenience kits containing MASTISOL liquid adhesive. The adhesive vials have defective tubing that can crack when used, potentially compromising the sterility and function of the kits. About 40 units were affected.

  • Check if you have any of the listed Medline kit SKUs (CDS984347O, CDS984857N, DYNJ0966130K, DYNJ51440B, DYNJ58742J, DYNJ63781B, DYNJ82751B, DYNJ82753C, or DYNJ907206G).
  • Do not use kits with the affected lot numbers listed in the recall notice.
  • Contact Medline Industries for instructions on returning or replacing the kits.
  • If a kit was already used, inform your healthcare provider.
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The agency's original wording
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.

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
40 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, Kit SKU CDS984347O; 2) HEAD AND NECK CDS-LF, Kit SKU CDS984857N; 3) NECK PACK-LF, Kit SKU DYNJ0966130K; 4) NECKLINE PACK-LF, Kit SKU DYNJ51440B; 5) THYROID PACK, Kit SKU DYNJ58742J; 6) ENT I, Kit SKU DYNJ63781B; 7) NECK PACK, Kit SKU DYNJ82751B; 8) NOSE PACK, Kit SKU DYNJ82753C; 9) WMC COCHLEAR IMPLANT ADD ON, Kit SKU DYNJ907206G.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1190-2026

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