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
TF8-32-63-90     TFFA070213    
TF8-32-63-90     TFFA070912    
TF8-32-81-135   TFFH070912    
TF8-32-81-37     TFFD070912    
TF8-32-81-45     TFFE070912    
TF8-32-81-55     TFFF070912    
TF8-32-81-90     TFFG070912    
TF8-38-62-S        TFFA201212    
TF85-32-63-37    TFFC070912    
TF85-32-63-45    TFFA221211    
TF85-32-63-45    TFFA250512    
TF85-32-63-45    TFFC051212    
TF85-32-63-45    TFFC230812    
TF85-32-63-55    TFFA230113    
TF85-32-63-55    TFFA290812    
TF85-32-63-55    TFFB070612    
TF85-32-63-90    TFFB230812    
TF85-32-63-90    TFFC260413    
TF85-32-63-90    TFFC280213    
TF85-32-63-90    TFFF070213    
TF85-32-81-135  TFFC280912    
TF85-32-81-37    TFFA280912    
TF85-32-81-90    TFFB280912