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Recall Observatory FDA recall evidence

Device product

G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ devices and (2) Needle-Pro¿ Devices with 22G x 1¿needles 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-1191-2014

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-1191-2014

Official wording

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

Code information: 2491431

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