RecallRadar

FDA Device recall Z-1183-2014

4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and ice bag Arterial Blood Sam…

On 2014-03-19 the FDA classified a Class II recall of 4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and ice bag Arterial Blood Sam… 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

AgencyFDA Device
Recall numberZ-1183-2014
ClassificationClass II
Statusterminated
Initiated2013-11-22
Published2014-03-19
Last updated2026-09-13 11:53 UTC
CompanySmiths Medical Asd
DistributionAL, 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

4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and ice bag 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_info2489881 2503429 2513713 2525788 2555872 2472514

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-1183-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.