Excelsior Medical Recalls Sterile Triple Lead Tubing Sets Due to Leak Risk
Excelsior Medical is recalling sterile triple lead tubing sets because a molding defect may allow fluid leaks or air entry during use.
What this means for you
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 defect that poses a risk of harm (fluid leak/air entry) 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
Excelsior Medical Corp is recalling the Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. These products are used with the Pharm-Assist Dispensing Pump for drug reconstitution and fluid transfer. The recall involves 4,250 tubing sets distributed nationwide in the United States and in Canada.
The recall is due to a potential leak caused by a molding defect in the connector that joins the three leads to the main flow line. This defect may allow fluid to escape or air to enter the fluid path during the transfer of fluids from one container to another.
The affected product codes are PA03 and BX03. Specific lot numbers for PA03 are 03030813, 03050813, and 03091213. Specific lot numbers for BX03 are 64031513, 64073113, 64081313, and 64090513. Users should check their inventory for these specific codes and lot numbers.
The recalled product
- 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
- Manufacturer
- Excelsior Medical Corp
- Category
- Medical Device — Tubing
- Hazard
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 (6)
- Product Code PA03 - Lot Nos.: 03030813
- 03050813 and 03091213 Product Code BX03
- Lot Nos.: 64031513
- 64073113
- 64081313
- 64090513
Distribution
Distributed nationwide across the United States.
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