The Recall Desk
HighFDA (Devices)·Z-0540-2023·Announced 2022-12-21

Surgical Procedure Trays with Potentially Compromised Sterile Packaging

Stradis Healthcare is recalling surgical procedure trays due to potentially incomplete outer bag sealing that may compromise product sterility. Affected units were distributed nationwide 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: This FDA Class II recall involves a surgical device with potential sterility compromise. While no illnesses or injuries have been reported, this is a risk-of-harm product where sterility breach could allow contamination of surgical instruments, meeting the High severity criterion.

Plain-English summary

Stradis Healthcare is recalling STRADIS HEALTHCARE Phleb surgical procedure trays and kits (Item No. 682-1425) because the outer bag may be incompletely sealed due to certain manufacturing conditions. This incomplete sealing could result in a breach in the sterility of the kit.

The recalled trays and kits were distributed nationwide in the United States and Canada. The affected lot number is 22236490624, and the recall involves 20 units.

A breach in sterility could allow exposure of the medical instruments and materials to contamination. These are surgical procedure kits intended for medical use.

The recalled product

Product
STRADIS HEALTHCARE, Phleb, Item No.682-1425,
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical Procedure Trays
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) M75268214251
  • UDI/DI (kit)M75268214250
  • Serial/Lot Numbers: 22236490624

Distribution

Distributed nationwide across the United States.

Related recalls

Same category