The Recall Desk
HighFDA (Devices)·Z-2156-2023·Announced 2023-07-26

FDA Recalls Medline Probe Cover Kits Due to Seam Defects

Medline is recalling probe cover kits used in diagnostic ultrasound procedures. The probe covers may have an inadequate barrier at the seams, which could compromise sterility during 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: FDA Class II recall affecting a medical device used directly in patient procedures. The inadequate seam barrier presents a risk of compromised sterility during ultrasound-guided procedures. No illnesses, injuries, or hospitalizations have been reported. This fits the criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Medline Industries, LP is recalling Probe Cover Kits containing sterile Ultrasound Gel across 30 different model numbers, including DYNJ81722, DYNJRA0827A, DYNJRA0881, and others, used during diagnostic ultrasound procedures.

The probe covers in these kits may have an inadequate barrier at the seams. This defect could compromise the sterile field during ultrasound-guided procedures.

Approximately 28,568 units were distributed worldwide between December 2017 and May 2023. Distribution included the United States and nine other countries: United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, and Panama.

Healthcare providers and patients who have received these kits should contact Medline Industries regarding return and replacement options. Affected units should not be used for patient care procedures.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ81722; b) PAIN BLOCK TRAY, Model Number DYNJRA0827A; c) PAIN PREP TRAY W/PROBE COVER, Model Number DYNJRA0881; d) PAIN PREP TRAY W/PROBE COVER, Model Numbe
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Diagnostic Ultrasound Probe Covers
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 (20)

  • all lots within expiry
  • UDI/DI (EA) 10195327136437
  • UDI/DI (CS)40195327136438
  • b) Model Number DYNJRA0827A
  • UDI/DI (EA) 10193489214468
  • UDI/DI (CS)40193489214469
  • c) Model Number DYNJRA0881
  • UDI/DI (EA) 10889942463930
  • UDI/DI (CS)40889942463931
  • d) Model Number DYNJRA0881A
  • UDI/DI (EA) 10195327262402
  • UDI/DI (CS)40195327262403
  • e) Model Number DYNJRA1603
  • UDI/DI (EA) 10193489299007
  • UDI/DI (CS)40193489299008
  • f) Model Number DYNJRA1739A
  • UDI/DI (EA) 10193489924954
  • UDI/DI (CS)40193489924955
  • g) Model Number DYNJRA1823
  • UDI/DI (EA) 10193489961881

Distribution

Distributed nationwide across the United States.

Related recalls

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