Philips OmniWire guide wire recalled for potential sterilization failure
Volcano Corp is recalling 11 Philips OmniWire Pressure guide wires distributed in Washington, Wisconsin, and Canada due to a potential failed sterilization process.
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 involving a potential sterilization failure on a medical device. No illnesses, injuries, or hospitalizations have been reported, and the hazard is theoretical. Per the rubric, recalls with theoretical hazards and no reported harm are scored at most 3 (High).
Plain-English summary
The Philips OmniWire Pressure guide wire (Model 89185J, Part Number 300000252891) is being recalled by Volcano Corp due to a potential failed sterilization process.
The recall involves 11 devices distributed in the United States (Washington and Wisconsin) and Canada. The affected serial numbers are 37583, 37586, 37590, 37598, 37612, 37648, 37655, 37692, 37694, 37709, and 37719.
No illnesses or injuries have been reported in connection with this recall. Healthcare providers and patients who have received one of these devices should contact Volcano Corp for further guidance regarding this recall.
The recalled product
- Product
- Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
- Manufacturer
- Volcano Corp
- Affected units
- 11
Distribution
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