Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED

FDA device recall Z-1730-2015 · posted 2015-06-08 · Terminated

Recall details

Recalling firm

Smiths Medical Asd Inc

Reason for recall

Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Set) where under-sized tubing was used in the production of 1 lot of product.

Action taken

Smiths Medical sent Urgent Medical Device Recall Notice letters, dated 4 May 2015, requiring its customers to return all affected unused Extension Sets. Please take the following actions: 1. Customers are to inspect their inventory and quarantine any affected Extension Sets. 2. Complete and return the attached Confirmation Form by Fax or by e-mail 3. Upon receipt of the completed form, a customer service representative will contact customers to arrange for exchange of their unused affected Extension Sets for credit or replacement. The notice shall be passed on to all personnel who need to be aware, including points of use. If these affected Extension Sets have been further distributed to other persons or facilities, please promptly forward the recipients a copy of this Urgent Medical Device Recall Notice.

Root cause

Process control

Status

Terminated

Product code

FPA

Quantity affected

6,000 units

Distribution

Distributed to the states of KY, MN, NJ, UT, & WI.

Date initiated

2015-05-04

Date posted

2015-06-08

Date terminated

2016-01-20

Location

Dublin, OH

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