The Recall Desk
HighFDA (Devices)·Z-2160-2023·Announced 2023-07-26

Medline Probe Cover Kits Recalled for Inadequate Seam Barriers

Medline is recalling 173,449 sterile probe cover kits due to inadequate seam barriers that may compromise sterility. The affected units were distributed worldwide between December 2017 and May 2023.

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 recall is classified as High severity (Class II) because the probe covers are risk-of-harm medical devices with a structural barrier defect that could allow contamination during procedures where sterility is critical. No illnesses or injuries have been reported in the source, which prevents classification as Severe.

Plain-English summary

Medline Industries, LP is recalling Probe Cover Kits containing sterile ultrasound gel used during diagnostic ultrasound procedures, angiography, cardiac catheterization, dialysis insertion, and other medical procedures. The recall involves 173,449 units across multiple product models manufactured and distributed between December 2017 and May 2023.

The probe covers may have an inadequate barrier at the seams. This defect could potentially allow contamination of the product during medical procedures where sterility is critical.

The affected kits were distributed worldwide, including throughout the United States and internationally to the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. Specific model numbers are listed in the FDA recall notice (Z-2160-2023).

Healthcare providers and patients with these probe cover kits should discontinue use and contact Medline Industries with questions. The FDA has classified this as a Class II recall.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRAPE PACK, Model Number 00-400305R; b) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936C; c) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936D; d) ANGIOGRAM, Model Number DYNJ0
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Sterile Probe Covers
Hazard
  • barrier-defect
  • contamination-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)

  • all lots within expiry
  • UDI/DI (EA) 10193489944280
  • UDI/DI (CS) 40193489944281
  • b) Model Number DYNJ0037936C
  • UDI/DI (EA) 10195327031282
  • UDI/DI (CS) 40195327031283
  • c) Model Number DYNJ0037936D
  • UDI/DI (EA) 10195327129538
  • UDI/DI (CS) 40195327129539
  • d) Model Number DYNJ0149444N
  • UDI/DI (EA) 10193489966718
  • UDI/DI (CS) 40193489966719
  • e) Model Number DYNJ0198765G
  • UDI/DI (EA) 10889942053988
  • UDI/DI (CS) 40889942053989
  • f) Model Number DYNJ0275614F
  • UDI/DI (EA) 10889942174348
  • UDI/DI (CS) 40889942174349
  • g) Model Number DYNJ0290716M
  • UDI/DI (EA) 10195327088866

Distribution

Distributed nationwide across the United States.

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