The Recall Desk
HighFDA (Devices)·Z-2166-2023·Announced 2023-07-26

Medline Probe Cover Kits Recalled for Inadequate Seam Barriers

Medline is recalling probe cover kits used in cardiac and vascular ultrasound procedures due to inadequate seam barriers. Over 3.7 million units were distributed worldwide from December 2017 through 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 an FDA Class II recall of sterile surgical probe covers used in high-risk cardiac and vascular procedures. While no illnesses or injuries have been reported, the inadequate seam barrier poses a theoretical risk of compromising sterility during surgical procedures, which could lead to infection. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medline Industries is recalling probe cover kits containing sterile ultrasound gel used during cardiac and vascular ultrasound procedures. The recalled kits may have inadequate barriers at the seams, which could potentially compromise the sterile integrity of the covers during use.

The recall affects 44 distinct model numbers used in multiple surgical applications, including open heart surgery, vascular intervention, valve replacement, transcatheter aortic valve replacement (TAVR), extracorporeal membrane oxygenation (ECMO), pacemaker procedures, arteriovenous fistula creation, and endovascular procedures. Approximately 3.7 million units were distributed worldwide between December 2017 and May 2023 to facilities in the United States, United Arab Emirates, Singapore, Lebanon, China, Qatar, Costa Rica, India, Canada, Panama, and Saudi Arabia.

Healthcare providers and facilities that have these probe cover kits should contact Medline Industries for information regarding the recall and any necessary replacement or corrective actions.

The recalled product

Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) SILVER CROSS OPEN HEART, Model Number DYNJ906102G; b) SILVER CROSS OPEN HEART, Model Number DYNJ906102I; c) CUSTOM CARDIAC CABG, Model Number DYNJ906108C; d) VASCULAR STENT INOVA, Model N
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Equipment
Hazard
  • sterile-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)10195327290795
  • UDI/DI (CS)40195327290796
  • b) Model Numbers DYNJ906102I
  • UDI/DI (EA)10195327323349
  • UDI/DI (CS)40195327323340
  • c) Model Numbers DYNJ906108C
  • UDI/DI (EA)10195327118273
  • UDI/DI (CS)40195327118274
  • d) Model Numbers DYNJ906440A
  • UDI/DI (EA)10193489312874
  • UDI/DI (CS)40193489312875
  • e) Model Numbers DYNJ906878A
  • UDI/DI (EA)10193489391305
  • UDI/DI (CS)40193489391306
  • f) Model Numbers DYNJ906882A
  • UDI/DI (EA)10193489391237
  • UDI/DI (CS)40193489391238
  • g) Model Numbers DYNJ906883A
  • UDI/DI (EA)10193489398205

Distribution

Distributed nationwide across the United States.

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