Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Surgical Equipment

Medline Pediatric Liver Access Kits Recalled for Non-Sterile Catheters

Agency Publication Date: February 14, 2025
Share:
Sign in to monitor this recall

Summary

Medline Industries is recalling 36 units of the Medline RR-LIVER TRNS ACCESSORY PEDS pediatric liver access convenience kits. These medical procedure kits were assembled using specific Coloplast Foley and Prostatic catheters that have been recalled due to potential sterility issues found during testing. The kits are used in clinical settings for pediatric patients; no injuries or incidents have been reported to date.

Risk

The catheters included in these kits may not be sterile, which can lead to serious infections like sepsis or localized tissue damage, especially in vulnerable pediatric patients undergoing liver access procedures.

What You Should Do

  1. This recall affects Medline RR-LIVER TRNS ACCESSORY PEDS medical procedure convenience kits (Ref/Catalog DUNJ63397) assembled with specific recalled catheters.
  2. Check your inventory for lot numbers 22HLA247, 21HLA443, 21JLA520, or 22GLA335. You can also identify the product by UDI/DI 10193489736755 (each) or 40193489736756 (case).
  3. Stop using the recalled product immediately.
  4. Contact Medline Industries or your medical distributor to arrange for the return, replacement, or correction of the kits.
  5. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Medline RR-LIVER TRNS ACCESSORY PEDS
Variants: Pediatric
Model / REF:
DUNJ63397
Lot Numbers:
22HLA247
21HLA443
21JLA520
22GLA335
UDI:
10193489736755
40193489736756

Medical procedure convenience kit

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96163
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Medical distributors; Hospitals
Manufactured In: United States
Units Affected: 36 units
Distributed To: California

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.