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Recall Observatory FDA recall evidence

Device product

4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) 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-1187-2014

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-1187-2014

Official wording

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

Code information: 2476330 2476331 2485112 2485113 2485115 2493970 2493971 2493972 2506817 2511213 2525787 2529542 2536822 2538273 2542763 2459801 2467733 2467734

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