Class II U.S. Food and Drug Administration

Medline convenience kits: Loop Pack Dynj61460C Open Heart CDS840150Y recall: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive

Recall published 4 months ago

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2418-2026
Published
June 24, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
49,654 kits total
Distribution
Nationwide
Made in
United States
Lot / code info
DYNJ61460C UDI-DI 10198459422133 lot 25KBA098 CDS840150Y UDI-DI 10198459303029 lots 25JBW220 26BBD028 DYNJ56297C UDI-DI 10198459513954 lot 25LMJ874 DYNJT3454 UDI-DI 10198459325663 lot 25KBG761 DYNJ33822L UDI-DI 10198459385582 lot 26AMA072 DYNJ900962O UDI-DI 10198459452581 lot 26CBC302 DYNJ54238L UDI-DI 10198459443114 lot 25LMH549 DYNJT6766 UDI-DI 10198459580888 lot 25KBM870 DYNJ909794C UDI-DI 10198459528002 lot 25LBF702 CVI5323A UDI-DI 10198459582035 lot 25KBM758 CDS983040M UDI-DI 10198459579813 lots 25KBO682 26BBB926
UPC codes
10198459422133, 10198459303029, 10198459513954, 10198459325663, 10198459385582, 10198459452581, 10198459443114, 10198459580888, 10198459528002, 10198459582035, 10198459579813

Products covered by this recall

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

Check your product

The notice names 13 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10198459422133
  • 10198459303029
  • 10198459513954
  • 10198459325663
  • 10198459385582
  • 10198459452581
  • 10198459443114
  • 10198459580888
  • 10198459528002
  • 10198459582035
  • 10198459579813

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 25KBO682 26BBB926 — 49
  • 654 kits total

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medline Industries, LP — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices recalled?

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10198459422133, 10198459303029, 10198459513954; lot code 25KBO682 26BBB926 — 49, 654 kits total. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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