CLASS II Device recall · Reported 22 Apr 2020 · FDA Enforcement Report

Portex LineDraw Arterial Blood Sampling Syringe recalled

Smiths Medical ASD is recalling Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and, distributed in 34 states. The recall was initiated on 7 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPortex LineDraw Arterial Blood Sampling Syringe: Item Number Lot Number 4042-2 3848838 4042-2 3848878 4042-2 3856950 4042-2 3859774 4042LH 3856958 4042LH 3859747

Quantity recalled720,100 total devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1715-2020
FDA event ID: 84681
Recalling firm: Smiths Medical ASD, Keene, NH
Classification: Class II
Status: Terminated
Recall initiated: 7 Jan 2020
FDA classified: 15 Apr 2020
Reported: 22 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Syringes & Needles

Timeline

7 Jan 2020	Recall initiated by company
15 Apr 2020	Classified by FDA	+99 days
22 Apr 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.

Product as listed by the FDA

Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes

Where it was distributed

USA: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI,MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA. Int'l: CA, DE, AU.

Alabama Arkansas Arizona California Colorado Delaware Florida Georgia Iowa Idaho Illinois Indiana Kansas Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi

Questions about this recall

Is Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and recalled?

Yes. Smiths Medical ASD recalled Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and on 7 Jan 2020. The recall is Class II and its status is Terminated. Recall number Z-1715-2020.

Why was it recalled?

Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.

Which lots are affected?

Portex LineDraw Arterial Blood Sampling Syringe: Item Number Lot Number 4042-2 3848838 4042-2 3848878 4042-2 3856950 4042-2 3859774 4042LH 3856958 4042LH 3859747

Where was it sold?

USA: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI,MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA. Int'l: CA, DE, AU.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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