The Recall Desk
HighFDA (Devices)·Z-2202-2023·Announced 2023-07-26

Medline Sterile Probe Covers Recalled for Inadequate Seam Barriers

Medline is recalling 572 sterile probe cover kits due to inadequate barriers at the seams that may compromise sterility during ultrasound procedures. The affected products 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 a Class II FDA recall of a sterile medical device with a functional barrier defect. The inadequate seam barrier poses a risk of sterility compromise during diagnostic ultrasound procedures, meeting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medline Industries is recalling sterile Probe Cover Kits that contain ultrasound gel. The products may have an inadequate barrier at the seams, which could compromise the sterile status of the cover during diagnostic ultrasound procedures.

The recall affects four model types: CVC INFANT INSERTION PACK (Model CVI4770A), INSERTION BUNDLE (Model DT21275), VA MAINTENANCE PACK (Model EBSI1382), and MIDLINE DRESSING CHANGE KIT (Model EBSI1464). A total of 572 units were distributed worldwide, including to the United States and locations in the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia. The affected products were distributed between December 2017 and May 2023.

Patients and healthcare providers should stop using the affected products and contact Medline Industries for instructions on returns or replacements. The FDA has classified this as a Class II recall.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC INFANT INSERTION PACK, Model Number CVI4770A; b) INSERTION BUNDLE, Model Number DT21275; c) VA MAINTENANCE PACK, Model Number EBSI1382; d) MIDLINE DRESSING CHANGE KIT, Model Number
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Ultrasound / Diagnostic Equipment
Hazard
  • barrier-defect
  • 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 (12)

  • All lots within expiry
  • UDI/DI (EA) 10653160350828
  • UDI/DI (CS) 00653160350821
  • b) Model Number DT21275
  • UDI/DI (EA) 10653160318934
  • UDI/DI (CS) 00653160318937
  • c) Model Number EBSI1382
  • UDI/DI (EA) 10193489196269
  • UDI/DI (CS) 20193489196266
  • d) Model Number EBSI1464
  • UDI/DI (EA) 10193489198959
  • UDI/DI (CS) 20193489198956

Distribution

Distributed nationwide across the United States.

Related recalls

Same category