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Recall Observatory FDA recall evidence

Device product

Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes

Z-1715-2020

January 07, 2020

Class II

Product summary

Firm
Smiths Medical ASD, Inc.
Event
Event 84681
Status
Terminated
Classification
Class II
Quantity
720,100 total devices
Official record key
device-enforcement:Z-1715-2020

Official wording

Reason: Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.

Code information: Portex LineDraw Arterial Blood Sampling Syringe: Item Number Lot Number 4042-2 3848838 4042-2 3848878 4042-2 3856950 4042-2 3859774 4042LH 3856958 4042LH 3859747

Distribution pattern: USA: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI,MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA. Int'l: CA, DE, AU.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.