Baylis Medical Recalls ProTrack Microcatheter Due to Circumferential Shaft Defects
Baylis Medical Corp is recalling two lots of ProTrack Microcatheters due to potential circumferential defects along the device shaft.
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: The recall involves a medical device with a structural defect (circumferential defects) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baylis Medical Corp is recalling two lots of ProTrack Microcatheters. The ProTrack Microcatheter is a sterile, single-use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.
The recall is being conducted due to the possibility that the catheter may have circumferential defects along its shaft. The affected lots are CIFA180814 and CIFA080914. A total of 58 units were distributed nationwide in the states of MO, MA, OH, CA, AR, FL, GA, CO, TX, KY, NY, MI, WI, and OR.
Healthcare providers and facilities should stop using the affected lots and contact Baylis Medical Corp for further instructions on the recall.
The recalled product
- Product
- ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.
- Manufacturer
- Baylis Medical Corp *
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 58
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 (1)
- Lots CIFA180814 and CIFA080914
Distribution
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