The Recall Desk
HighFDA (Devices)·Z-0538-2023·Announced 2022-12-21

Stradis Healthcare Thoracic Surgery Kits Recalled for Sterility Risk

Thoracic Phleb procedure kits from Stradis Healthcare are being recalled due to incomplete outer bag sealing during manufacturing, which may compromise kit 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 is a Class II medical device recall involving surgical procedure kits where a manufacturing defect (incomplete bag sealing) poses a risk to patient safety through potential sterility breach. No injuries or illnesses have been reported to date, placing this within the 'risk-of-harm products where injury has not yet been reported' criterion.

Plain-English summary

Stradis Medical, LLC dba Stradis Healthcare is recalling STRADIS HEALTHCARE Thoracic Phleb surgical procedure kits (Item No. 682-1228). The affected kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may compromise the sterility of the surgical kits.

The recall affects 5 units that were distributed nationwide in the United States and Canada. The affected product can be identified by the following identifiers: UDI/DI (case) M7268212281, UDI/DI (kit) M7268212280, and Serial/Lot Number 22237491041.

The recalled product

Product
STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228,
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical Procedure Kit
Hazard
  • sterility-breach
  • packaging-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 (3)

  • UDI/DI (case) M7268212281
  • UDI/DI (kit)M7268212280
  • Serial/Lot Numbers: 22237491041

Distribution

Distributed nationwide across the United States.

Related recalls

Same category