The Recall Desk
HighFDA (Devices)·Z-0552-2023·Announced 2022-12-21

Surgical Procedure Kits Recalled for Incomplete Outer Bag Seal

Stradis Healthcare is recalling Varicosity Basic Pack surgical procedure kits (105 units) distributed in the US and Canada due to potentially incomplete outer bag sealing 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: FDA Class II recall of sterile medical devices with potential sterility breach due to manufacturing defect (incomplete outer bag sealing). No illnesses or injuries have been reported, qualifying this as a risk-of-harm product without reported injury per rubric Score 3 criteria.

Plain-English summary

Stradis Medical, LLC dba Stradis Healthcare is recalling Varicosity Basic Pack surgical procedure kits (Item No. 682-947, 105 units) distributed in the United States and Canada. The recalled kits have Lot Number 22236491032 and UDI/DI codes (case) M7526829471 and (kit) M7526829470.

The affected kits may have incompletely sealed outer bags due to certain manufacturing conditions. An incomplete seal could result in a breach in the sterility of the kit, potentially compromising the integrity of the medical device.

This is a precautionary recall based on the manufacturing defect, with no reported illnesses or injuries at this time.

The recalled product

Product
STRADIS HEALTHCARE, Varicosity Basic Pack, Item No.682-947,
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical Procedure Kits
Hazard
  • incomplete-seal
  • sterility-breach

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) M7526829471
  • UDI/DI (kit)M7526829470
  • Serial/Lot Numbers: 22236491032

Distribution

Distributed nationwide across the United States.

Related recalls

Same category