The Recall Desk
HighFDA (Devices)·Z-2175-2023·Announced 2023-07-26

Medline Probe Cover Kits Recalled for Inadequate Seam Barriers

Medline is recalling 2739 units of probe cover kits used in diagnostic ultrasound and catheter insertion procedures due to inadequate barriers at seams that could compromise sterility.

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 with a potential barrier and sterility-compromise hazard used in invasive procedures. No illnesses or injuries have been reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, meriting a High severity score. The hazard poses potential for serious infection in high-risk clinical procedures such as central line insertion.

Plain-English summary

Medline Industries is recalling probe cover kits containing sterile ultrasound gel used in diagnostic ultrasound and catheter insertion procedures. The recall affects six model numbers: CVI4880 (Catheter Insertion Kit CLABSI), CVI680C (Central Catheter Insertion Tray), DYNDC1786A (CVL Insertion Tray), ECVC1655 (Universal Insertion Kit), ECVC7880 (CVC Insertion Accessory Kit), and IVS3635B (Ultrasound Guided PIV Insertion Kit). These probe covers may have inadequate barriers at the seams, which could compromise the sterility of the product.

A total of 2739 units were distributed worldwide between December 2017 and May 2023 to healthcare facilities in the United States and internationally, including Canada, United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Panama, and Saudi Arabia.

Healthcare providers should quarantine any affected units immediately. Contact Medline Industries for replacement or disposal instructions. If these products were used in patient procedures, consult infection control to determine whether additional patient follow-up is needed.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETER INSERTION KIT CLABSI, Model Number CVI4880; b) CENTRAL CATHETER INSERTION TRA, Model Number CVI680C; c) CVL INSERTION TRAY, Model Number DYNDC1786A; d) UNIVERSAL INSERTION K
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Diagnostic and Catheter Insertion Kits
Hazard
  • barrier-defect
  • 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 (18)

  • all lots within expiry
  • UDI/DI (EA) 10195327233976
  • UDI/DI (CS) 40195327233977
  • Model Number CVI680C
  • UDI/DI (EA) 10653160992943
  • UDI/DI (CS) 40653160992944
  • Model Number DYNDC1786A
  • UDI/DI (EA) 10193489199116
  • UDI/DI (CS) 40193489199117
  • Model Number ECVC1655
  • UDI/DI (EA) 10653160254935
  • UDI/DI (CS) 40653160254936
  • Model Number ECVC7880
  • UDI/DI (EA) 10195327129613
  • UDI/DI (CS) 40195327129614
  • Model Number IVS3635B
  • UDI/DI (EA) 10653160992660
  • UDI/DI (CS) 40653160992661

Distribution

Distributed nationwide across the United States.

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