Device recall: 4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device…

Class II FDA enforcement event 66837. Recall start date: 22 Nov 2013. Status in the FDA record: Terminated. Termination date: 20 Nov 2020.

Reason for recall, in the words of FDA

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

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Smiths Medical ASD, Inc. started this device recall on 22 Nov 2013. The firm address in the FDA record is in Keene, NH. FDA put the recall in Class II. FDA event 66837 has 13 product records. The first FDA enforcement report date is 19 Mar 2014. The record gives the status Terminated, with the termination date 20 Nov 2020.

FDA enforcement report The 13 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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.…

Recalling firm

Smiths Medical ASD, Inc., Keene, NH.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

13 product records in the event.

FDA event 66837: product records
Recall number	Product	Quantity	Class	Status	Report date
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 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…	N/A	Class II	Terminated	19 Mar 2014
Z-1181-2014	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.	N/A	Class II	Terminated	19 Mar 2014
Z-1182-2014	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.	N/A	Class II	Terminated	19 Mar 2014
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 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.	N/A	Class II	Terminated	19 Mar 2014
Z-1184-2014	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.…	N/A	Class II	Terminated	19 Mar 2014
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 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.	N/A	Class II	Terminated	19 Mar 2014
Z-1186-2014	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…	N/A	Class II	Terminated	19 Mar 2014
Z-1187-2014	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…	N/A	Class II	Terminated	19 Mar 2014
Z-1188-2014	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…	N/A	Class II	Terminated	19 Mar 2014
Z-1189-2014	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…	N/A	Class II	Terminated	19 Mar 2014
Z-1190-2014	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.…	N/A	Class II	Terminated	19 Mar 2014
Z-1191-2014	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 1¿needles Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via…	N/A	Class II	Terminated	19 Mar 2014
Z-1192-2014	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…	N/A	Class II	Terminated	19 Mar 2014

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2013: 1,236
Share of these events in Class II: 90%
Product records in this event: 13Median of the firm: 1
Events of the firm on the register: 108

Other events of the firm

Other FDA enforcement events of Smiths Medical ASD, Inc.
Initiated	Product (first record)	Type	Class	Records
10 Apr 2025	CADD Solis HSPCA Pump *Updated 5/27/26* Scope updated to apply specifically to customers using the wireless system.	Device	Class I	1
10 Apr 2025	CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51	Device	Class I	2
10 Apr 2025	CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR	Device	Class I	2
14 Feb 2025	CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100	Device	Class II	2
13 Feb 2025	smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24	Device	Class I	12
13 Feb 2025	Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035	Device	Class I	1
28 Oct 2024	smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP	Device	Class II	3
24 Sep 2024	medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2	Device	Class II	24
18 Jul 2024	smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRW	Device	Class II	5
16 Jul 2024	CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD S	Device	Class I	1

Smiths Medical ASD, Inc.: all 108 events

Official channels

FDA enforcement report Z-1180-2014The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 66837. https://recallregister.com/fda/ii/66837/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this 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.…
What quantity of product is in FDA event 66837?: The event has 13 product records. The first record gives this quantity: N/A
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2013 have the same class?: 90% of the 1,236 device events that started in 2013 are in Class II.