The Recall Desk
HighFDA (Devices)·Z-2194-2023·Announced 2023-07-26

Medline Ultrasound Probe Cover Kits Recalled for Inadequate Barrier Seals

Medline is recalling 10,080 ultrasound probe cover kits because the seams may not seal properly, potentially compromising barrier protection. The kits were distributed worldwide from December 2017 through 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 is an FDA Class II medical device recall involving a structural defect in a product used in clinical procedures. The defect (inadequate seals at seams) presents a theoretical risk of barrier failure and potential contamination, though no illnesses or injuries have been reported.

Plain-English summary

Medline Industries is recalling 10,080 probe cover kits containing sterile ultrasound gel. The affected products span multiple model numbers and are designed for use in diagnostic ultrasound procedures, particularly during central venous catheter insertion.

The probe covers may have an inadequate barrier at the seams, which could compromise barrier integrity.

The recalled kits were distributed worldwide between December 2017 and May 2023 to medical facilities throughout the United States and internationally, including Canada, the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Panama, and Saudi Arabia.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model Number ECVC1320; b) CENTRAL VENOUS CATH INSERTION BUNDLE PI, Model Number ECVC1345A; c) TRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC149
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Ultrasound Probe Covers
Hazard
  • inadequate-barrier
  • 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 (CS) 00653160335798
  • b) Model number ECVC1345A: UDI/DI (EA) 10653160334606
  • UDI/DI (CS) 00653160334609
  • c) Model number ECVC1490A: UDI/DI (EA) 10653160359036
  • UDI/DI (CS) 00653160359039
  • d) Model number ECVC1495A: UDI/DI (EA) 10653160358794
  • UDI/DI (CS) 00653160358797
  • e) Model number ECVC1725: UDI/DI (EA) 10653160334507
  • UDI/DI (CS) 00653160334500
  • f) Model number ECVC1915: UDI/DI (EA) 10653160334446
  • UDI/DI (CS) 00653160334449
  • g) Model number ECVC1970B: UDI/DI (EA) 10653160357155
  • UDI/DI (CS) 00653160357158
  • h) Model number ECVC2001: UDI/DI (EA) 10653160334415
  • UDI/DI (CS) 00653160334418
  • i) Model number ECVC2205A: UDI/DI (EA) 10653160357148
  • UDI/DI (CS) 00653160357141
  • j) Model number ECVC2240A: UDI/DI (EA) 10653160334361
  • UDI/DI (CS) 00653160334364

Distribution

Distributed nationwide across the United States.

Related recalls

Same category