The Recall Desk
HighFDA (Devices)·Z-2167-2023·Announced 2023-07-26

Medline Probe Cover Kits: Inadequate Seam Barrier Risk

Medline probe cover kits used in ultrasound-guided medical procedures may have inadequate barriers at the seams, posing a contamination risk. Approximately 270,000 units distributed worldwide since December 2017 are affected.

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 sterile medical device kits used in invasive ultrasound-guided procedures. The identified seam barrier defect poses a contamination risk in products essential to maintaining procedural sterility. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High severity.

Plain-English summary

Medline Industries is recalling probe cover kits containing sterile ultrasound gel. These kits are used to maintain sterility during diagnostic ultrasound procedures, particularly those involving ultrasound-guided needle insertion such as central line placement, PICC line insertion, and arterial access. The recalled kits include multiple model numbers and configurations.

The probe covers may have an inadequate barrier at the seams. This defect could compromise the sterility of the kit during use, potentially allowing contamination of the ultrasound probe or the sterile field during diagnostic or procedural ultrasound guidance.

Approximately 269,985 units were distributed worldwide between December 2017 and May 2023. Distribution included healthcare facilities throughout the United States and internationally in the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. All lots within the product's expiration date are affected.

Healthcare providers should review their stock of these products and consider discontinuing use of recalled units. For product-specific identification and additional details, refer to FDA Medical Device Recall notice Z-2167-2023.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL BUNDLE NO CATHETER, Model Number ART995; b) ART LINE KIT NO CATH, Model Number ARTNC145; c) CENTRAL LINE TRAY, Model Number CVI4705; d) CENTRAL LINE INSERTION PACK, Model Number
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Diagnostic Ultrasound / Probe Covers
Hazard
  • seam-defect
  • contamination-risk
  • sterility-compromise

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) 10193489190502
  • UDI/DI (CS) 40193489190503
  • b) Model Number ARTNC145
  • UDI/DI (EA) 10195327306762
  • UDI/DI (CS) 40195327306763
  • c) Model Number CVI4705
  • UDI/DI (EA) 10193489832372
  • UDI/DI (CS) 40193489832373
  • d) Model Number CVI4805
  • UDI/DI (EA) 10195327068714
  • UDI/DI (CS) 40195327068715
  • e) Model Number CVI4865
  • UDI/DI (EA) 10195327235260
  • UDI/DI (CS) 40195327235261
  • f) Model Number CVI4950A
  • UDI/DI (EA) 10195327351960
  • UDI/DI (CS) 40195327351961
  • g) Model Number DT22260
  • UDI/DI (EA) 10653160329190

Distribution

Distributed nationwide across the United States.

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