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

FDA device recall Z-2070-2014 · posted 2014-07-16 · Terminated

Recall details

Recalling firm

Excelsior Medical Corp

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.

Action taken

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 (recall12@excelsiormedical.com).

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LHI

Quantity affected

4250 tubing sets (PA03 - 78 cases; BX03 - 92 cases (each case contains 25 tubing sets))

Distribution

Worldwide Distribution - USA (nationwide) and Canada.

Date initiated

2014-06-05

Date posted

2014-07-16

Date terminated

2015-08-19

Location

Neptune, NJ

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