The Recall Desk
HighFDA (Devices)·Z-3034-2024·Announced 2024-09-18

Medline Convenience Kits With Syringes Recalled for Leaks and Breakage

Medline convenience kits containing plastic syringes are being recalled worldwide due to leaks and breakage that may pose patient health risks. The kits are linked to an FDA Safety Alert issued March 19, 2024.

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: FDA Class II recall without reported illnesses or injuries. The hazard involves quality defects in medical equipment (leaks, breakage) that may pose patient health risk, qualifying as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling multiple models of medical convenience kits that contain plastic syringes. The recalled kits include models labeled as KIT MIDSTREAM W/BZK/FUNNL (Pack Number DYND30212), PROCESSING KIT 3 (Pack Number DYNJ65728A), 30ML KIT (Pack Number DYNJ82155A), DISSECTION (Pack Number DYNJ85191), and FLAP HARVEST PACK (Pack Number DYNJ58575C).

These kits have been identified with quality defects including leaks, breakage, and other quality issues. These defects are related to an FDA Safety Alert issued on March 19, 2024, and may pose a risk to patient health when the affected syringes are used in medical procedures.

The recalled kits have been distributed worldwide. Healthcare facilities and providers who have received these kits should identify affected units using the provided pack numbers and lot numbers, and should not use the affected kits in patient care.

If you have received any of these affected kits, stop using them immediately and contact Medline Industries for instructions on return or replacement.

The recalled product

Product
Medline Convenience kits labeled as: 1) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number DYND30212; 2) PROCESSING KIT 3 PTE0000204 , Pack Number DYNJ65728A ; 3) 30ML KIT, Pack Number DYNJ82155A ; 4) DISSECTION, Pack Number DYNJ85191; 5) FLAP HARVEST PACK , Pack Number DYNJ5
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • breakage
  • leaks

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)

  • DYND30212
  • Lot Number 20CBV412
  • DYND30212H
  • DYNJ58575C
  • Lot Number 22FMF260
  • Lot Number 22EMI154
  • Lot Number 22JMF580
  • DYNJ65728A
  • Lot Number 21IBJ821
  • Lot Number 21IBV204
  • Lot Number 21JBE157
  • DYNJ82155A
  • Lot Number 23CBD960
  • Lot Number 23CBH024
  • Lot Number 23DBL430
  • Lot Number 23EBI493
  • Lot Number 23FBO135
  • Lot Number 23FBO795
  • Lot Number 23GBJ181
  • Lot Number 23HBJ559

Distribution

Distribution scope not specified by the agency.