Z-2070-2014Class II

Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. To be used...

Name: Z-2070-2014 Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. To be used...
Creator: Excelsior Medical Corp
Published: 2014-06-05
License: https://open.fda.gov/license/

Excelsior Medical LLC / initiated 2014-06-05 / Terminated / root cause: manufacturing process

FDA source

Excelsior Medical Corp began a recall of 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... on 2014-06-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2070-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-05
Posted: 2014-07-16
Terminated: 2015-08-19
Recalling firm: Excelsior Medical LLC
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
Product code: LHI Set, I.V. 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Excelsior Medical issued "Urgent Medical Device Recall" notifications/"Customer Reply Forms" dated June 5, 2014 to affected customers via certified mail (return receipt request). The notice informed customers of the issue with the affected product; how to identify affected product; instructed the customers to discontinue use of tubing sets from the affected lots and return the attached form (Customer Reply Form) via fax to Excelsior to make arrangements for return of product. If product was further distributed by the customer the notification instructs them to identify the customer(s) that it was supplied to and notify them at once of the product recall. A phone number was provided in case customers had questions regarding the recall (1.800.487.4276 8:30 am - 5:00 pm EST) as well as an email address ([email protected]).
Quantity in commerce: 4250 tubing sets (PA03 - 78 cases; BX03 - 92 cases (each case contains 25 tubing sets))
Distribution: Worldwide Distribution - USA (nationwide) and Canada.
Product codes and lots: Product Code PA03 - Lot Nos.: 03030813, 03050813 and 03091213 Product Code BX03, Lot Nos.: 64031513, 64073113, 64081313, 64090513

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2070-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2070-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-16

Product code LHI

K913804Class IIExcelsior Single Lead Dispensing SetExcel Medical, Inc. / cleared 1992-02-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)