The Recall Desk
HighFDA (Devices)·Z-0500-2023·Announced 2022-12-21

Stradis Healthcare Introducer Kit Micro recalled for potential sterility compromise

Stradis Healthcare is recalling 180 units of its Introducer Kit Micro cardiovascular devices due to potential incomplete sealing of outer bags that may compromise sterility.

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 recall involves a cardiovascular medical device with a potential sterility assurance risk, classified as FDA Class II. The source text contains no reports of illnesses, injuries, or hospitalizations, indicating the hazard is theoretical rather than realized. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

Stradis Medical, LLC dba Stradis Healthcare is recalling 180 units of the STRADIS HEALTHCARE Introducer Kit Micro (Item No. 525-038), a cardiovascular medical device.

The recall was initiated because manufacturing conditions may result in incomplete sealing of the outer bag. An incompletely sealed bag could compromise the product's sterility assurance.

The affected kits were distributed throughout the United States and Canada.

The recalled product

Product
STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascular
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Cardiovascular / Surgical Kit
Hazard
  • incomplete-seal
  • sterile-barrier-compromise

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 (3)

  • UDI/DI (case) M7525250381
  • UDI/DI (kit)M7525250380
  • Serial/Lot Numbers: 22251491752

Distribution

Distributed nationwide across the United States.

Related recalls

Same category