Recall Z-2070-2014— Excelsior Medical Corp
Class II · Terminated
Class II FDA medical device recall by Excelsior Medical Corp, initiated 2014-06-05, terminated 2015-08-19. It names one FDA 510(k) clearance: K913804. Product: Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. To be used with the Pharm-Assist Dispensing Pump. Used for drug reconstitution and/or fluid transfer. Reason: There is a potential for a leak. A molding defect in the connector that joins the three leads to the main flow line may allow fluid to escape or air to enter the fluid path during transfer of fluids from one container to another..
- Recalling firm
- Excelsior Medical Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-05
- Terminated
- 2015-08-19
- Firm location
- Neptune, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. To be used with the Pharm-Assist Dispensing Pump. Used for drug reconstitution and/or fluid transfer
Reason for recall
There is a potential for a leak. A molding defect in the connector that joins the three leads to the main flow line may allow fluid to escape or air to enter the fluid path during transfer of fluids from one container to another.
Data sourced from openFDA. This site is unofficial and independent of the FDA.