FDA Device recall Z-1180-2014

4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, 22g x 1¿ needle, and…

FDA Device
Class II
terminated
Published 2014-03-19

On 2014-03-19 the FDA classified a Class II recall of 4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, 22g x 1¿ needle, and… by Smiths Medical Asd, citing issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1180-2014
Classification	Class II
Status	terminated
Initiated	2013-11-22
Published	2014-03-19
Last updated	2026-09-13 11:53 UTC
Company	Smiths Medical Asd
Distribution	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

Product

4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, 22g x 1¿ needle, and Point-Lok¿ needle safety device 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.

Reason

issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes

Identifiers

code_info	2485103 2493959 2498064 2511207 2521581 2525780 2525781 2533316 2547272 2574207 2578556 2472508 2476319 2467728 2497730

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1180-2014%22

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