FDAFDA · Food and drugs·Recall number 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.
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
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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