Z-1730-2015Class II

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

Name: Z-1730-2015 Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE...
Creator: Smiths Medical Asd Inc
Published: 2015-05-04
License: https://open.fda.gov/license/

Abbott Medical / initiated 2015-05-04 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical Asd Inc began a recall of Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek... on 2015-05-04. FDA classified it as Class II and gives the reason as "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". 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-1730-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-04
Posted: 2015-06-08
Terminated: 2016-01-20
Recalling firm: Abbott Medical
Product: Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 6,000 units
Distribution: Distributed to the states of KY, MN, NJ, UT, & WI.
Product codes and lots: Product Reorder Number: 537235C; Lot #2761409

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1730-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1730-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-08

Product code FPA

K831087Class IIMini-Vol Extension SetBeech Medical, Inc. / cleared 1983-04-28

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)