FDA Device recall Z-1185-2014
4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro¿ device Arterial Blood Sampling Line Draw S…
- FDA Device
- Class II
- terminated
- Published 2014-03-19
On 2014-03-19 the FDA classified a Class II recall of 4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro¿ device Arterial Blood Sampling Line Draw S… 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-1185-2014 |
| 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
4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro¿ 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 | 2459795 2476328 2503425 2521590 2529540 2533322 2551265 2560930 2569055 2574218 |
|---|
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-1185-2014%22
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