The Recall Desk
HighFDA (Devices)·Z-0537-2023·Announced 2022-12-21

Stradis Healthcare Phlebectomy Pack Recall Due to Sterility Breach Risk

Stradis Healthcare recalls its Phlebectomy Pack (Item No. 682-001) due to incomplete sealing of outer bags, which may compromise sterility of surgical kits distributed nationwide.

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 Class II recall involves incomplete sealing of outer bags in surgical kits, which may compromise sterility. Per the severity rubric, Class II recalls describing risk-of-harm products with no reported illnesses or injuries qualify as 'High' severity (score 3).

Plain-English summary

Stradis Medical, LLC dba Stradis Healthcare is recalling the STRADIS HEALTHCARE Phlebectomy Pack (Item No. 682-001), a medical and surgical procedure kit. The product was distributed nationwide throughout the United States and Canada, affecting 15 units.

The recall was initiated due to manufacturing conditions that may result in the outer bag being incompletely sealed. An incompletely sealed outer bag may result in a breach in the sterility of the kit.

The FDA classified this as a Class II recall.

The recalled product

Product
STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001,
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical Kit
Hazard
  • sterility-breach
  • seal-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) M7526820011
  • UDI/DI (kit)M7526820010
  • Serial/Lot Numbers: 22236489633

Distribution

Distributed nationwide across the United States.

Related recalls

Same category