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Recall Observatory FDA recall evidence

Device product

Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial Blood Sampling Kit is intended for sampling arterial blood for the measurement of blood gasses, Cooximetry, electrolytes, total magnesium, and metabolites, (Glucose and Lactate).

Z-1028-2015

December 17, 2014

Class III

Product summary

Firm
Smiths Medical ASD, Inc.
Event
Event 70034
Status
Terminated
Classification
Class III
Quantity
900 units
Official record key
device-enforcement:Z-1028-2015

Official wording

Reason: The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit Label is marked with 08-2017 which exceeds the actual expiration date by one year.

Code information: Lot Number: 2782094

Distribution pattern: US in the state of FL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit Label is marked with 08-2017 which exceeds the actual expiration date by one year.