Possible Bloodstream Contamination Leads to Class I Recall
On September 23, 2013 Montreal, Canada-based Baylis Medical Company sent an urgent device recall letter to its customers.
As reported by the U.S. Food and Drug Administration (FDA) on November 6, 2013, the Class I recall affects 1,035 TorFlex Transseptal Guiding Sheath Kits that were manufactured between December 22, 2011 and July 24, 2013 (part and lot numbers reported below).
Class I recalls are reserved for such situations in which there is a reasonable probability that the product will cause serious adverse health consequences or death.
The sheath kit is a single use device designed for safe and easy catheterization and angiography of specific heart chambers and locations. The components include a sheath, a dilator, and a J-tipped guide wire.
According to the FDA, the kit has been recalled because the sheath could remove particulate of less than 5 mm from the dilator. The particulate could then potentially migrate into the patient’s bloodstream.
Baylis has instructed customers to examine their inventory, quarantine affected lots, and sign and return a Medical Device Correction Acknowledgment Form directly to the company.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program.
Possible thoughts on the design flaw? Comment below.
Part Lot Number