CLASS II Device recall · Reported 23 Jul 2014 · FDA Enforcement Report
Sterile Triple Lead Tubing Set recalled by Excelsior Medical
Excelsior Medical is recalling Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set, distributed nationwide in the US. The recall was initiated on 5 Jun 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2070-2014
- FDA event ID
- 68573
- Recalling firm
- Excelsior Medical, Neptune, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jun 2014
- FDA classified
- 16 Jul 2014
- Reported
- 23 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 5 Jun 2014 | Recall initiated by company | |
| 16 Jul 2014 | Classified by FDA | +41 days |
| 23 Jul 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Worldwide Distribution - USA (nationwide) and Canada.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Product Code PA03 - Lot Nos.: 03030813, 03050813 and 03091213 Product Code BX03, Lot Nos.: 64031513, 64073113, 64081313, 64090513
Where was it sold?
Worldwide Distribution - USA (nationwide) and Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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