The Recall Desk
HighFDA (Devices)·Z-2159-2023·Announced 2023-07-26

Medline Probe Cover Kits Recalled for Inadequate Seam Barrier

Medline is recalling probe cover kits used during diagnostic ultrasound procedures due to an inadequate barrier at the seams that may compromise sterile integrity.

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 recall for a manufacturing defect (inadequate seam barrier) that creates a risk of compromised sterility in a sterile medical device used in clinical procedures. No adverse events or illnesses have been reported, but the defect represents a risk-of-harm in an essential safety-critical product.

Plain-English summary

Medline Industries is recalling probe cover kits containing sterile ultrasound gel for use during diagnostic ultrasound procedures. Approximately 55,014 units were distributed worldwide between December 2017 and May 2023, including to healthcare facilities in the United States, United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia.

The probe covers may have an inadequate barrier at the seams. This defect could allow the sterile integrity of the covers to be compromised during diagnostic procedures.

Healthcare facilities and clinical personnel with affected probe cover kits should stop using the product immediately and contact Medline Industries for instructions regarding returns and replacement options.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH, Model Number 00-401318M; b) ANGIOGRAPHY OR, Model Number CDS984944C; c) ANGIOGRAM, Model Number DYNJ0149444M; d) EP LAB DEVICE PACK-LF, Model Number DYNJ0
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Ultrasound probe cover / diagnostic accessory
Hazard
  • barrier-defect
  • sterility-defect

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)10193489348750
  • UDI/DI (CS)40193489348751 b) Model Number CDS984944C
  • UDI/DI (EA)10889942172955
  • UDI/DI (CS)40889942172956 c) Model Number DYNJ0149444M
  • UDI/DI (EA)10193489432824
  • UDI/DI (CS)40193489432825 d) Model Number DYNJ0160556D
  • UDI/DI (EA)10193489207552
  • UDI/DI (CS)40193489207553 e) Model Number DYNJ0201109AG
  • UDI/DI (EA)10193489497267
  • UDI/DI (CS)40193489497268 f) Model Number DYNJ0373279M
  • UDI/DI (EA)10193489519020
  • UDI/DI (CS)40193489519021 g) Model Number DYNJ0429121I
  • UDI/DI (EA)10193489897494
  • UDI/DI (CS)40193489897495 h) Model Number DYNJ0806254D
  • UDI/DI (EA)10889942471164
  • UDI/DI (CS)40889942471165 i) Model Number DYNJ0854485T
  • UDI/DI (EA)10193489864199
  • UDI/DI (CS)40193489864190 j) Model Number DYNJ17624B
  • UDI/DI (EA)10193489867299

Distribution

Distributed nationwide across the United States.

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