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Recall Observatory FDA recall evidence

Device product

Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes

Z-1716-2020

January 07, 2020

Class II

Product summary

Firm
Smiths Medical ASD, Inc.
Event
Event 84681
Status
Terminated
Classification
Class II
Quantity
127,700 total devices
Official record key
device-enforcement:Z-1716-2020

Official wording

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

Code information: Portex Pro-Vent Arterial Blood Sampling Kit: Item Number Lot Number G1724 3859779 G1702 3863522 4599P-1 3859751 4599P-1 3862142 4599P-1 3863544 4599P-1 3863545 4599P-1 3869581 G1665 3856947 4588P-2 3862145 4558PE 3859727

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

    Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.