The Recall Desk
HighFDA (Devices)·Z-2304-2023·Announced 2023-08-09

Medline Procedural Kits Recalled for Potentially Non-Sterile Gel

Medline Industries is recalling 1,218 procedural kits because the sterile ultrasound gel component may not meet sterility specifications, potentially posing an infection risk in invasive 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: This is an FDA Class II device recall involving potential loss of sterility in a medical component used in invasive procedures. No illnesses or injuries have been reported. Per the severity rubric, recalls with theoretical hazards and no reported injuries are capped at Score 3 (High). The use case—invasive vascular procedures—elevates this above a moderate precautionary recall.

Plain-English summary

Medline Industries, LP is recalling 1,218 custom sterile and non-sterile procedural kits due to a potential defect with the ultrasound gel component. The affected products are Central Line Bundles (Model STCVC2020), Arterial Line Trays (Model ART905), Catheterless Insertion Kits (Model CVI4510), OR Catheter Insertion Setup Packs (Model ECVC7165A), Vantex 7FR 3L Central Venous Catheter Bundles (Model STCVC01145B), and Vantex Triple Lumen Bundles (Model STCVC2000).

The labeled sterile ultrasound gel component in these kits may not meet sterility specifications, creating a potential risk of infection when used in invasive procedures. The ultrasound gel is used during central line insertion, arterial line insertion, catheter insertion, and other clinical procedures.

The affected kits were distributed worldwide between April 1, 2020, and April 28, 2023. Distribution included the United States and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates.

Patients and healthcare providers who have these kits should stop using them and contact Medline Industries for instructions regarding product return and replacement.

The recalled product

Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 16CM CENTRAL LINE BUNDLE, Model Number: STCVC2020; b. ARTERIAL LINE TRAY, Model Number: ART905; c. CATHETERLESS INSERTION KIT, Model Number: CVI4510;
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Procedural Kits
Hazard
  • sterility-failure
  • infection-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 (6)

  • UPC Number: 10653160338765. b. Model Number: ART905
  • UPC Number: 10653160326557. c. Model Number: CVI4510
  • UPC Number: 10653160321194. d. Model Number: ECVC7165A
  • UPC Number: 10653160346760. e. Model Number: STCVC01145B
  • UPC Number: 10653160351924. f. Model Number: STCVC2000
  • UPC Number: 10653160336792.

Distribution

Distributed nationwide across the United States.

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