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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Hazard
- Affected units
- 40
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.
Part of a larger recall action
This product is one of 78 recalled by Stradis Medical, LLC dba Stradis Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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