The Recall Desk
HighFDA (Devices)·Z-2195-2023·Announced 2023-07-26

Medline Probe Cover Kits recalled for inadequate seam barrier

Medline is recalling 620 Probe Cover Kits due to an inadequate seam barrier that could compromise sterility during ultrasound procedures. The kits 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 is an FDA Class II recall of a sterile medical device used in invasive ultrasound-guided procedures. The inadequate seam barrier creates a risk of compromising sterility in a risk-of-harm product, and while no illnesses or injuries have been reported, the manufacturing defect warrants a High severity classification.

Plain-English summary

Medline Industries is recalling Medline Probe Cover Kits containing sterile ultrasound gel. The affected kits include three models: CATHETERLESS INSERTION KIT (Model CVI4510), VANTEX 7FR 3L 16CM CVC BUNDLE (Model STCVC01145B), and VANTEX TRIPLE LUMEN BUNDLE (Model STCVC2000). A total of 620 units are affected.

The probe covers may have an inadequate barrier at the seams, which could compromise the sterility of the product during diagnostic ultrasound procedures. These covers are designed to maintain a sterile environment and are used in ultrasound-guided procedural kits.

The affected kits were distributed worldwide from December 2017 through May 2023. Distribution included the United States (nationwide) and international locations: United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. All affected units remain within their expiration dates.

Healthcare facilities and providers who have received these kits should stop using them and contact Medline Industries for instructions on returning the product or obtaining replacements. This is an FDA Class II recall.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI4510; b) VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number STCVC01145B; c) VANTEX TRIPLE LUMEN BUNDLE, Model Number STCVC2000;
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Ultrasound Equipment
Hazard
  • contamination-risk
  • sterility-defect

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 (9)

  • All lots within expiry
  • UDI/DI (EA) 10653160321194
  • UDI/DI (CS) 00653160321197
  • b) Model Number STCVC01145B
  • UDI/DI (EA) 10653160351924
  • UDI/DI (CS) 00653160351927
  • c) Model Number STCVC2000
  • UDI/DI (EA) 10653160336792
  • UDI/DI (CS) 00653160336795

Distribution

Distributed nationwide across the United States.

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