The Recall Desk
HighFDA (Devices)·Z-0548-2023·Announced 2022-12-21

Stradis Healthcare Surgical Procedure Kits Recalled for Incomplete Sealing

Stradis Medical recalls Vein & Laser surgical procedure kits due to incomplete outer bag sealing that may compromise sterility. The recall affects 10 units distributed in the US and Canada.

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 surgical procedure kits with a manufacturing defect that could compromise sterility. The incomplete sealing of outer bags raises a risk of contamination of surgical instruments, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Stradis Medical, LLC dba Stradis Healthcare is recalling Vein & Laser surgical procedure trays and kits (Item No. 682-334R1). The recall affects 10 units distributed nationwide in the United States and Canada, with lot/serial number 22231489619.

During manufacturing, the outer bags of these surgical kits may have been incompletely sealed. An incomplete seal can result in a breach of the kit's sterility, which is critical for safe surgical use.

The recalled product

Product
STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical Trays / Procedure Kits
Hazard
  • seal-defect
  • 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) M752682334R11
  • UDI/DI (kit)M752682334R10
  • Serial/Lot Numbers: 22231489619

Distribution

Distributed nationwide across the United States.

Related recalls

Same category