The Recall Desk
HighFDA (Devices)·Z-2184-2023·Announced 2023-07-26

Medline Ultrasound Probe Covers Recalled for Inadequate Seam Barriers

Medline Industries is recalling ultrasound probe cover kits used in invasive procedure trays due to inadequate seam barriers that may allow contamination. The recall affects 11,413 units 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: FDA Class II medical device with potential contamination risk. The probe cover seam barrier defect qualifies as a risk-of-harm product used in invasive medical procedures where injury has not yet been reported, per the rubric criterion. No illnesses or injuries have been reported.

Plain-English summary

Medline Industries, LP is recalling ultrasound probe cover kits that contain sterile ultrasound gel. The product names include Laceration Tray, Ultrasound Guided IV/Midline Kit, Pediatric Central Line Kit, Central Line Tray, Central Line Pack Companion, PICC Line Pack, Customized Central Line Pack, Tunnel Line Pack, and Closure Pack. These kits are used for ultrasound-guided invasive medical procedures.

The probe covers may have an inadequate barrier at the seams. An inadequate barrier at the seams could potentially allow contamination during use.

A total of 11,413 units have been distributed worldwide. Products were distributed throughout the United States and internationally to the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia, beginning in December 2017 and continuing through May 2023.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY, Model Number DYNDL1134A; b) ULTRASOUND GUIDED IV/MIDLINE K, Model Number DYNDV2385; c) PEDIATRIC CENTRAL LINE KIT, Model Number DYNJ38885B; d) CENTRAL LINE TRAY, Mod
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Ultrasound Probe Cover Kits
Hazard
  • barrier-failure
  • 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 (20)

  • all lots within expiry
  • UDI/DI (EA) 10080196994762
  • UDI/DI (CS)40080196994763
  • b) Model Number DYNDV2385
  • UDI/DI (EA) 10193489475593
  • UDI/DI (CS)40193489475594
  • c) Model Number DYNJ38885B
  • UDI/DI (EA) 10193489462333
  • UDI/DI (CS)40193489462334
  • d) Model Number DYNJ42902B
  • UDI/DI (EA) 10888277798007
  • UDI/DI (CS)40888277798008
  • e) Model Number DYNJ47215D
  • UDI/DI (EA) 10888277743021
  • UDI/DI (CS)40888277743022
  • f) Model Number DYNJ47717A
  • UDI/DI (EA) 10193489454529
  • UDI/DI (CS)40193489454520
  • g) Model Number DYNJ60586
  • UDI/DI (EA) 10193489528046

Distribution

Distributed nationwide across the United States.

Related recalls

Same category