The Recall Desk
HighFDA (Devices)·Z-0539-2023·Announced 2022-12-21

Stradis Ablation Pack Recalled for Potentially Compromised Sterile Seal

Stradis Healthcare is recalling Ablation Pack Item No. 682-130 due to incomplete outer bag seals that may compromise sterility. The defect may allow contamination of surgical kits.

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 an FDA Class II recall of a medical device where seal integrity may be compromised, creating a theoretical risk of sterility loss. Per the rubric, this meets the 'High' threshold as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Stradis Medical, LLC dba Stradis Healthcare is recalling the Ablation Pack, Item No. 682-130 (40 units). The recall resulted from manufacturing conditions that may have caused the outer bag to be incompletely sealed, which could result in a breach in the sterility of the kit.

The affected product was distributed nationwide throughout the United States and in Canada. Healthcare facilities and users who have received the recalled kits should discontinue use and contact the manufacturer for return or replacement instructions.

The recalled product

Product
STRADIS HEALTHCARE, Ablation Pack, Item No.682-130,
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical / Ablation Kits
Hazard
  • 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) M7526821301
  • UDI/DI (kit)M7526821300
  • Serial/Lot Numbers: 22237491040

Distribution

Distributed nationwide across the United States.

Related recalls

Same category