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Recall Observatory FDA recall evidence

Device product

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.

Z-1180-2014

November 22, 2013

Class II

Product summary

Firm
Smiths Medical ASD, Inc.
Event
Event 66837
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1180-2014

Official wording

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

Code information: 2485103 2493959 2498064 2511207 2521581 2525780 2525781 2533316 2547272 2574207 2578556 2472508 2476319 2467728 2497730

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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