The Recall Desk
HighFDA (Devices)·Z-0553-2023·Announced 2022-12-21

STRADIS HEALTHCARE Surgical Procedure Trays Recalled for Incomplete Sterile Sealing

STRADIS HEALTHCARE surgical procedure trays and kits are being recalled due to a manufacturing condition that may result in incomplete sealing of the outer bag, potentially compromising 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 for a potential sterility breach. Although the hazard is theoretical in nature, incomplete sealing of medical procedure trays poses a significant risk of patient harm through contamination, qualifying as a risk-of-harm product.

Plain-English summary

STRADIS HEALTHCARE is recalling medical and surgical procedure trays and kits (Item No. 686-142, Lot 22236491028) distributed in the United States and Canada. The recall is due to a manufacturing condition that may result in incomplete sealing of the outer bag.

The incomplete sealing may result in a breach of the kit's sterility. Patients undergoing medical or surgical procedures with these kits could potentially be exposed to contamination.

This is an FDA Class II medical device recall.

The recalled product

Product
STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142,
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical Procedure Tray
Hazard
  • sterility-breach
  • incomplete-seal
  • contamination-risk

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) M7526861421
  • UDI/DI (kit)M7526861420
  • Serial/Lot Numbers: 22236491028

Distribution

Distributed nationwide across the United States.

Related recalls

Same category