FDA-Device2026-06-24Class IIPROCESSING DEFECT
Medline surgical convenience kits recalled for defective adhesive tubing
OTHERNationwide distribution
Medline surgical kits recalled for adhesive tubing defect
Multiple Medline surgical convenience kits contain a recalled batch of Ferndale Laboratories MASTISOL Liquid Adhesive with defective tubing. The butyrate tubing may crack when used, making the adhesive unusable during surgical procedures.
- Check your Medline convenience kit against the specific lot numbers listed in the recall notice.
- Do not use affected kits in surgical procedures.
- Contact Medline or your supplier for replacement or instructions on returning the affected kits.
Hazard
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Sold states
US Nationwide distribution. OUS distribution pending.
Affected count
49,654 kits total
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ56297C PACEMAKER PK DYNJT3454 PACEMAKER/ICD PACK DYNJ33822L PAD OPEN HEART DYNJ900962O PEDIATRIC OPEN HEART DYNJ54238L DYNJT6766 STAZ BASIC VASCULAR DYNJ909794C VASCULAR ACCESS KIT CVI5323A VASCULAR CDS CDS983040M
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2418-2026More Medline Industries, LP recalls
- FDA-Device2026-06-24Medline medical procedure kits recalled for catheter defects and connector detachment risk
- FDA-Device2026-06-24Medline cardiac surgery kits recalled for catheter defects
- FDA-Device2026-06-24Medline dressing change kits recalled for defective adhesive tubing
- FDA-Device2026-06-24Medline open-heart and cardiac surgery kits recalled for catheter defects
- FDA-Device2026-06-24Medline laparoscopy procedure kits recalled for catheter defects
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