The Recall Desk
HighFDA (Devices)·Z-2775-2024·Announced 2024-09-04

Medical procedure packs containing defective syringes recalled by Medline

Medline is recalling Centurion procedure packs with plastic syringes that have leaks, breakage, and other quality issues. These defects may pose a risk to patient health.

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 recall of medical devices with identified quality defects that may pose a risk to patient health. No injuries or illnesses are reported in the source. This fits the High severity criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Medline Industries is recalling Centurion procedure packs containing plastic syringes with identified quality defects. The affected packs include multiple types of surgical and medical procedure kits: Arthrograph Tray, Breast Biopsy Kit, Circumcision Trays, NICU Circumcision Tray, Nursery Circumcision Tray, Punch Biopsy Kit, and Sterile 1cc Syringe with Needle. Multiple lot numbers across all affected product types are included in this recall.

The syringes in these packs have been identified with leaks, breakage, and other quality issues related to an FDA Safety Alert issued on March 19, 2024. These defects may pose a risk to patient health during medical procedures.

The affected products have been distributed worldwide. Healthcare facilities that have received these products should verify the lot numbers of their inventory. The FDA has classified this as a Class II recall.

The recalled product

Product
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAPH TRAY, Pack Name MNS12670A; 2) BREAST BIOPSY KIT, Pack Name DYNDH1512A; 3) CIRCUMCISION TRAY, Pack Name CIT6720; 4) CIRCUMCISION TRAY, Pack Name CIT6715; 5) CIRCUMCISION TRAY, Pack Name CIT7
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • syringe-defect
  • leakage
  • 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 (20)

  • MNS12670A
  • Lot Number 2022011090
  • Lot Number 2022070690
  • Lot Number 2023022190
  • Lot Number 2023101890
  • Lot Number 2024021590
  • DYNDH1512A
  • Lot Number 2022121990
  • CIT6720
  • Lot Number 2021061490
  • CIT6715
  • Lot Number 2022100490
  • CIT7020
  • Lot Number 2023010690
  • DYNDA2271
  • Lot Number 2023082290
  • Lot Number 2023102090
  • Lot Number 2023120590
  • CIT6920
  • Lot Number 2021082390

Distribution

Distribution scope not specified by the agency.