CLASS II Device recall · Reported 19 Mar 2014 · FDA Enforcement Report
G2001: Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U recalled
Smiths Medical ASD is recalling G2001: Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with, distributed in 40 states. The recall was initiated on 22 Nov 2013 and the FDA has classified it as Class II.
Check your package
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-1192-2014
- FDA event ID
- 66837
- Recalling firm
- Smiths Medical ASD, Keene, NH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Nov 2013
- FDA classified
- 12 Mar 2014
- Reported
- 19 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 22 Nov 2013 | Recall initiated by company | |
| 12 Mar 2014 | Classified by FDA | +110 days |
| 19 Mar 2014 | 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
issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
Product as listed by the FDA
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.
Where it was distributed
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.
AlabamaArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouri
Questions about this recall
Why was it recalled?
issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
Which lots are affected?
2548332
Where was it sold?
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.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
12 other products · FDA event 66837This product is part of a recall event; the main page for the event is 4042LH: Line Draw, Luer lock syringe (heparin concentration: 7 I.U recalled.
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