The Recall Desk
HighFDA (Devices)·Z-1439-2025·Announced 2025-04-02

Medline Procedure Kits With Defective Plastic Syringes Recalled

Medline is recalling surgical procedure kits with plastic syringes affected by a March 2024 FDA Safety Alert due to leaks, breakage, and quality issues that may pose risks to patients.

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: Medical device recall with identified quality defects (leaks, breakage) in surgical procedure kits that may pose risk to patient health. No illnesses or injuries reported; hazard is documented but harm not yet realized.

Plain-English summary

Medline Industries, LP is recalling seven medical procedure kits containing plastic syringes. The syringes are affected by issues identified in an FDA Safety Alert issued March 19, 2024. The identified defects include leaks, breakage, and quality issues that may pose a risk to patient health.

The recall involves approximately 398 units distributed nationwide in the United States and to Canada. The affected kits are: AV Fistula Pack-LF, Barrington Accessory TTL Knee, CVL Insertion Pack, KT Dr. Velasco Fistula Pack, PICC Abscess Pack-LF, PICC/RAD Spec Proc, and VAP Pack-LF.

Specific lot numbers and UDI codes are available for each kit variant to identify the affected products. For more information about this recall, consult the FDA and Medline Industries.

The recalled product

Product
Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNEE, Pack Number DYNJ56717A; 3) CVL INSERTION PACK, Pack Number CVI5065; 4) KT DR VELASCO FISTULA PACK, Pack Number DYNJ46648D; 5) PICC ABSCESS PACK-LF, Pac
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Procedure Kits
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 (12)

  • Lot Number 23GMB253A
  • 2) Pack Number DYNJ56717A : UDI/DI 10889942897940 (each) 40889942897941 (case)
  • Lot Number 21EBM603A
  • 3) Pack Number CVI5065 : UDI/DI 10195327504366 (each) 40195327504367 (case)
  • Lot Number 23LMH242A
  • 4) Pack Number DYNJ46648D : UDI/DI 10193489755244 (each) 40193489755245 (case)
  • Lot Number 20HMC528A
  • Lot Number 21EMA842Z
  • 6) Pack Number DYNJ32773G : UDI/DI 10193489766134 (each) 40193489766135 (case)
  • Lot Number 21IMG907A
  • 7) Pack Number PHS656578F : UDI/DI 10889942804535 (each) 40889942804536 (case)
  • Lot Number 20LKB006A

Distribution

Distributed nationwide across the United States.

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