Oscor SafeSheath ULTRALITE 10F Recalled for Potential Open Sterile Seal
Oscor, Inc. is recalling 500 units of the AngioDynamics SafeSheath ULTRALITE 10F due to a potential open seal on the sterile product.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Oscor, Inc. is recalling 500 units of the AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10. The recall is being conducted because of a potential for an open seal on the sterile product.
The affected devices are identified by GUDID 25051684026298 and Lot Number DP-11759. These devices were distributed nationwide in the United States, specifically within the state of New York.
The SafeSheath ULTRALITE 10F is intended for the introduction of various types of pacing leads and catheters. Healthcare facilities and users should stop using the affected devices and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
- Manufacturer
- Oscor, Inc.
- Hazard
- Affected units
- 500
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 (2)
- GUDID: 25051684026298
- Lot Number DP-11759
Distribution
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