Z-1186-2014Class II

4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device...

Name: Z-1186-2014 4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device...
Creator: Smiths Medical ASD, Inc.
Published: 2013-11-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-11-22 / Terminated

FDA source

Smiths Medical ASD, Inc. began a recall of 4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Europe only) Arterial Blood Sampling... on 2013-11-22. FDA classified it as Class II and gives the reason as "issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1186-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-22
Posted: 2014-03-12
Terminated: 2020-11-20
Recalling firm: Abbott Medical
Product: 4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes
FDA root cause: Component change control
Action: Smiths Medical sent an Urgent Field Safety Notice dated November 22, 2013, to all affected consignees via FedEx beginning on November 23, 2013. Distributors were instructed to notify their customers. Customers were instructed to inspect their inventory for the affected product and quarantine the affected syringes. Complete and return the attached Urgent Field Safety Notice Confirmation Form by fax to 603-358-1017 or by email to [email protected]. Upon receipt of the completed form, a customer service representative will contact them to arrange for exchange of their unused affecte devices for credit or replacement. Customers were instructed to forward the notice to all personnel who need to be aware within their organization and to any organization where the potentially affected devices have been transferred. Customers were instructed to report any issues with the product to Smiths Medical's Global Complaint Department at 1-866-216-8806 or [email protected]. For questions regarding this recall call 603-352-3812.
Distribution: Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.
Product codes and lots: 2476326 2480611 2493966 2493967 2506812 2506813 2529537 2529539 2533321 2536818 2536820 2547286 2459794 2463880 2463881

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1186-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1180-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-12
Z-1181-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-12
Z-1182-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-12
Z-1183-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-12
Z-1184-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-12
Z-1185-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-12
Z-1186-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-12
Z-1187-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-12
Z-1188-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-12
Z-1189-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-12
Z-1190-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-12
Z-1191-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-12
Z-1192-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-12

Product code JKA

K952516Class IIPro-Vent, Line Draw, PulsatorSmiths Industries Medical Systems, Inc. / cleared 1995-07-14

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)