FDAFDA · Food and drugs·Recall number 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 an arterial line. The product is not for injection.
Published March 19, 2014 · Recall initiated: November 22, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smiths Medical ASD, Inc.
- Distributor
- 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.
- Lot
- 2485103 2493959 2498064 2511207 2521581 2525780 2525781 2533316 2547272 2574207 2578556 2472508 2476319 2467728 2497730
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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