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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Event Detail

Event ID 66837
Product Type Devices
Status Ongoing
Recalling Firm Smiths Medical ASD, Inc.
City Keene
State NH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-22
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern 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 Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
4043E: 3 mL Line Draw, Luer slip 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. 2476330 2476331 2485112 2485113 2485115 2493970 2493971 2493972 2506817 2511213 2525787 2529542 2536822 2538273 2542763 2459801 2467733 2467734 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Z-1187-2014
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. 2476326 2480611 2493966 2493967 2506812 2506813 2529537 2529539 2533321 2536818 2536820 2547286 2459794 2463880 2463881 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Z-1186-2014
4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro® device Arterial Blood Sampling Line Draw 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. 2459795 2476328 2503425 2521590 2529540 2533322 2551265 2560930 2569055 2574218 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Z-1185-2014
4043W-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro® device, syringe tip cap and 6 mL Luer slip syringe 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. 2485116 2489882 2498071 2503431 2506818 2511214 2521593 2533326 2542764 2547293 2555873 2560933 2569066 2578565 2459802 2472515 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Z-1184-2014
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 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. 2489881 2503429 2513713 2525788 2555872 2472514 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Z-1183-2014
4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 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. 2459798 2472512 2472513 2476329 2480613 2480614 2489880 2493968 2498070 2503427 2506816 2511212 2513711 2521591 2521592 2525786 2529541 2533323 2547290 2547291 2551266 2555870 2560932 2569056 2569057 2569058 2463882 2467732 2574219 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Z-1182-2014
4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 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. 2463876 2472511 2476324 2476325 2480609 2485108 2489875 2493965 2503422 2503423 2506814 2511211 2513709 2521588 2529536 2533320 2536817 2547283 2551262 2551263 2560919 2560920 2569052 2569053 2574217 2463876 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Z-1181-2014
4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro® device, 22g x 1½ 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. 2485103 2493959 2498064 2511207 2521581 2525780 2525781 2533316 2547272 2574207 2578556 2472508 2476319 2467728 2497730 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Z-1180-2014
G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro® device, Needle-Pro® Device and 23G x 1 needle 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. 2548332 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Z-1192-2014
G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro® devices and (2) Needle-Pro® Devices with 22G x 1½needles 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. 2491431 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Z-1191-2014
G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro® device, syringe tip cap, and 5 mL Luer lock syringe 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. 2483968 2492596 2496746 2500736 2505477 2514016 2524048 2529356 2536681 2541173 2554034 2475168 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Z-1190-2014
G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro® device and 1 mL Line Draw Luer slip syringe (heparin concentration: 23.5 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. 2530465 2530465 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Z-1189-2014
G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro® device (for sale in Japan 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. 2467804 2480661 2503528 2503529 2521653 2529597 2529598 2551329 2572218 2572220 2467805 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Z-1188-2014
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