The Recall Desk
HighFDA (Devices)·Z-2176-2023·Announced 2023-07-26

Medline Probe Cover Kits Recalled for Inadequate Seam Barriers

Medline is recalling 4,644 sterile ultrasound gel probe cover kits with potentially inadequate seams that could compromise barrier integrity during ultrasound procedures.

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 of medical device with seam barrier defect that creates risk of contamination during sterile ultrasound procedures. No illnesses or injuries reported; hazard is theoretical but presents risk of harm in clinical use.

Plain-English summary

Medline Industries, LP is recalling 4,644 sterile ultrasound gel probe cover kits distributed from December 2017 through May 2023. The recall affects four model kits: CVC PACK (Model DYNJ46967F), ENDOVENOUS CORE PACK (Model DYNJ62557), ENSEMBLE CATHETER DIALYSE-LF (Model DYNJ81973), and TVS4000 ENDOVENOUS PACK (Model TVS4000K).

The probe covers may have an inadequate barrier at the seams. This defect could allow contamination during ultrasound procedures when the covers are used to maintain sterile conditions.

The affected devices were distributed worldwide to the United States and internationally to United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia.

Affected healthcare facilities and users should verify their inventory using the provided model numbers and UDI codes to identify recalled units.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F; b) ENDOVENOUS CORE PACK, Model Number DYNJ62557; c) ENSEMBLE CATHETER DIALYSE-LF, Model Number DYNJ81973; d) TVS4000 ENDOVENOUS PACK, Model Num
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device
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 (8)

  • all lots within expiry
  • UDI/DI (EA) 10193489576047UDI/DI (CS) 40193489576048
  • b) Model Number DYNJ62557
  • UDI/DI (EA) 10193489669152UDI/DI (CS) 40193489669153
  • c) Model Number DYNJ81973
  • UDI/DI (EA) 10195327204877UDI/DI (CS) 40195327204878
  • d) Model Number TVS4000K
  • UDI/DI (EA) 10816982023862UDI/DI (CS) 40816982023863

Distribution

Distributed nationwide across the United States.

Related recalls

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