The Recall Desk
HighFDA (Devices)·Z-0174-2025·Announced 2024-10-30

Medline convenience kits recalled for potential use of non-sterile product

Medline brand obstetric convenience kits packaged in breather pouch lot 323080002 may become non-sterile if the vendor seal is opened or unsealed.

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: The recall is classified as FDA Class II. While no illnesses or injuries have been reported, these are sterile medical devices used in surgical and delivery procedures. Non-sterile products in this context present a clear risk of infection, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries is recalling certain convenience kits used in obstetric and delivery procedures. The recalled kits were packaged in breather pouch lot 323080002 and may result in the use of non-sterile product if the vendor seal is opened or unsealed.

The affected kits include 76 different product configurations with a total of 12,583 units distributed worldwide, including the United States, Canada, and Panama. The specific affected product codes and lot numbers are detailed in the FDA recall notice.

The recalled product

Product
Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF DYNJ0213264O; 2) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 3) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K; 4) VAGINAL DELIVERY, REF DYNJ04865M; 5) VAGINAL DELIVERY PACK-LF, RE
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Obstetric Procedure Kits
Hazard
  • non-sterile
  • infection-risk

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)

  • 1) REF DYNJ0213264O
  • UDI/DI 40193489411912 (each)
  • 10193489411911 (case)
  • Lot Numbers: 23LBP214
  • 2) REF DYNJ0375486K
  • UDI/DI 40889942232865 (each)
  • 10889942232864 (case)
  • Lot Numbers: 23LBQ906
  • 3) REF DYNJ0375486K
  • Lot Numbers: 23KBO506
  • 4) REF DYNJ04865M
  • UDI/DI 40195327188123 (each)
  • 10195327188122 (case)
  • Lot Numbers: 23LBP871
  • 5) REF DYNJ0536939R
  • UDI/DI 40195327206223 (each)
  • 10195327206222 (case)
  • Lot Numbers: 24ABC134
  • 6) REF DYNJ07831F
  • UDI/DI 40888277841131 (each)

Distribution

Distributed nationwide across the United States.

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