The Recall Desk
HighFDA (Devices)·Z-2995-2024·Announced 2024-09-18

Medline cardiac and surgical procedure convenience kits recalled worldwide

Medline Industries recalled cardiac and surgical procedure convenience kits distributed worldwide including pacemaker, angiography, and open heart surgery kits.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: These are high-risk cardiac surgical devices classified as FDA Class II. While no injuries or illnesses have been reported in the available source, these sterile surgical kits are used in critical cardiac procedures where device failure could result in serious patient harm. The recall of widely distributed surgical kits warrants a High severity rating.

Plain-English summary

Medline Industries, LP of Northfield, Illinois has issued an ongoing recall of multiple cardiac and surgical procedure convenience kits for worldwide distribution. The recalled products include permanent pacing kits, pacemaker trays, femoral packs, cardiac catheterization packs, coronary angiography packs, left heart trays, electrophysiology lab pacemaker packs, and open heart surgery packs identified by multiple pack numbers and lot numbers.

These sterile surgical kits are used in hospital operating rooms and cardiac catheterization laboratories for critical procedures including permanent pacemaker implantation, cardiac catheterization, coronary angiography, and open heart surgery.

Healthcare facilities that have received affected kits should identify units by pack number and lot number against the detailed lists provided by the FDA. Contact Medline Industries at the manufacturer address in Northfield, Illinois for instructions regarding affected product handling or replacement.

The recalled product

Product
Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2) NORTON CHILDRENS CATH LAB-LF, Pack Number 00-401185Q ; 3) PACEMAKER TRAY, Pack Number 00-401521F ; 4) FEMORAL PACK, Pack Number 00-401525G ; 5) CARDIAC CATH PACK , Pack Number 00-401561K ;
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical kits - cardiac procedures
Hazard
  • device-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 00-400361J
  • Lot Number 19GMA398
  • Lot Number 19KMB977
  • Lot Number 20AMB625
  • Lot Number 20CMB790
  • Lot Number 20EMB935
  • Lot Number 20HMD638
  • Lot Number 20JMF103
  • Lot Number 20LMD909
  • Lot Number 21HMA255
  • Lot Number 21HMD608
  • Lot Number 21JMG396
  • Lot Number 21LMF121
  • Lot Number 22AME293
  • Lot Number 22BMF391
  • Lot Number 22HMA827
  • Lot Number 22LMA159
  • Lot Number 23CMA918
  • Lot Number 23EMG313
  • Lot Number 23HME323

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category