The Recall Desk
HighFDA (Devices)·Z-2766-2024·Announced 2024-09-04

Centurion procedure kits recalled due to defective plastic syringes

Medline Industries is recalling Centurion procedure kits containing plastic syringes with leaks and breakage issues. The defective syringes may pose a risk to patient health during medical procedures.

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: This is a Class II medical device recall with identified quality defects (leaks and breakage) in syringes used in medical procedures. Although no injuries or illnesses have been reported in the source text, defective syringes in invasive procedures represent a risk of harm to patients, meeting the criterion for a high-severity recall.

Plain-English summary

Medline Industries is recalling Centurion procedure kits distributed worldwide. The affected kits include biopsy kits, biopsy skin/laceration trays, chest tube insertion trays, custom biopsy trays, peritonsillar abscess trays, pre-dialysis trays, and stereo procedure trays. These kits contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024.

The recalled syringes have been identified with leaks, breakage, and other quality issues. These defects may pose a risk to patient health during medical procedures.

The recall affects specific lot numbers of these kits. Healthcare facilities should verify which kits they have in inventory and check the lot numbers against the recall notice to identify any affected units.

The recalled product

Product
Centurion procedure kits labeled as: 1) BIOPSY KIT, Pack Number DYNDA1466A; 2) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 3) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 4) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 5) PERITONSILLAR ABSCESS TRAY, Pack Number MN
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • syringe-leak
  • syringe-breakage

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 (13)

  • DYNDA1466A
  • Lot Number 2022040190
  • SUT20455
  • CHT560
  • Lot Number 2021092290
  • MNS4815
  • MNS3560
  • Lot Number 2021021790
  • Lot Number 2021092890
  • Lot Number 2022071490
  • Lot Number 2023121290
  • DYNDC3274
  • DYNDC2859A

Distribution

Distribution scope not specified by the agency.