The Recall Desk
HighFDA (Devices)·Z-2170-2023·Announced 2023-07-26

Medline Ultrasound Probe Cover Kits Recalled for Inadequate Seam Barriers

Medline is recalling probe covers used in ultrasound procedures that may have inadequate seam barriers. No illnesses have been reported.

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 medical device recall with potential risk to patient safety due to inadequate sterile barriers during invasive procedures. The source does not report any illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).

Plain-English summary

Medline Industries is recalling 47,185 probe cover kits used during diagnostic ultrasound procedures. The probe covers may have inadequate barriers at the seams, which could compromise the integrity of the sterile field during medical procedures.

The recall affects multiple probe cover models distributed from December 2017 through May 2023. Affected units were distributed throughout the United States and internationally, including the United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia.

The FDA classified this as a Class II recall. No illnesses or injuries related to this defect have been reported to date.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST BIOPSY KIT, Model Number DYNDA1224B; b) U/S CORE BIOPSY KIT, Model Number DYNDH1121C; c) BIOPSY PACK, Model Number DYNDH1124; d) REVAMP BIOPSY TRAY, Model Number DYNDH1147A; e
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device
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) 10193489468519
  • UDI/DI (CS) 40193489468510
  • b) Model Number DYNDH1121C
  • UDI/DI (EA) 10193489468656
  • UDI/DI (CS) 40193489468657
  • c) Model Number DYNDH1124
  • UDI/DI (EA) 10889942303274
  • UDI/DI (CS) 40889942303275
  • d) Model Number DYNDH1147A
  • UDI/DI (EA) 10193489348798
  • UDI/DI (CS) 40193489348799
  • e) Model Number DYNDH1266
  • UDI/DI (EA) 10889942670451
  • UDI/DI (CS) 40889942670452
  • f) Model Number DYNDH1345A
  • UDI/DI (EA) 10888277732933
  • UDI/DI (CS) 40888277732934
  • g) Model Number DYNDH1496A
  • UDI/DI (EA) 10193489825312

Distribution

Distributed nationwide across the United States.

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