Class II U.S. Food and Drug Administration

Medline convenience kits: BIB AV Fistula Pack Dynj58304B Cardiac Minor 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

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

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-2444-2026
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
DYNJ58304B UDI-DI 10195327512699 Lot 25LBP470 DYNJ56573B UDI-DI 10193489903669 Lot 25KBK220 DYNJ29135N UDI-DI 10195327674755 Lot 25LMG563 DYNJ65916B UDI-DI 10193489902044 Lots 25KBG852 25LBB895 CDS983672P UDI-DI 10198459149139 Lots 25LBO027 26BBB852 DYNJ21877W UDI-DI 10195327104542 Lot 25JBW040 DYNJ39316D UDI-DI 10198459224447 Lot 25KBH774 DYNJ58354F UDI-DI 10195327515232 Lot 25KBI240 DYNJ0618174N UDI-DI 10195327227340 Lot 25KBC715 DYNJ35761D UDI-DI 10195327565374 Lot 26CBC772 DYNJ0972604A UDI-DI 10889942403905 Lot 25LMF965 CDS983686I UDI-DI 10193489852981 Lot 26ABE755 DYNJ52059D UDI-DI 10195327361785 Lots 25LBQ917 26CBE736 DYNJ43663A UDI-DI 10193489793680 Lot 26CBB662 DYNJ45640B UDI-DI 10193489494983 Lot 25LMJ305
UPC codes
10195327512699, 10193489903669, 10195327674755, 10193489902044, 10198459149139, 10195327104542, 10198459224447, 10195327515232, 10195327227340, 10195327565374, 10889942403905, 10193489852981, 10195327361785, 10193489793680, 10193489494983

Products covered by this recall

Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT PACK DYNJ56573B ENDOVASCULAR PACK DYNJ29135N EP DEVICE DYNJ65916B FULL LINE ANEURYSM CDS CDS983672P GEN FEM POP #14-RF DYNJ21877W IMPLANT PACK DYNJ39316D OPEN HEART MRNGSD DYNJ58354F PACEMAKER PACK-LF DYNJ0618174N PACEMAKER SETUP PACK DYNJ35761D PACER / CATH LAB PACK-LF DYNJ0972604A PACER CDS CDS983686I PACER PACK DYNJ52059D PK, EP LAB PACEMAKER DYNJ43663A VENOUS ACCESS PACK DYNJ45640B

Check your product

The notice names 17 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.

  • 10195327512699
  • 10193489903669
  • 10195327674755
  • 10193489902044
  • 10198459149139
  • 10195327104542
  • 10198459224447
  • 10195327515232
  • 10195327227340
  • 10195327565374
  • 10889942403905
  • 10193489852981
  • 10195327361785
  • 10193489793680
  • 10193489494983

Lot or batch code

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

  • 25LMJ305 — 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 — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  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.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

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 10195327512699, 10193489903669, 10195327674755; lot code 25LMJ305 — 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?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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