—#132165

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).

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K952516
Affected lot / code info: Lot Number: 2782094

Why it was recalled

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.

Root cause (FDA determination)

Employee error

Action the firm took

Smiths Medical notified American Medical Depot via telephone on 12 December 2014. Smiths Medical instructed them to put product at their location on hold. American Medical Depots customer will be instructed to return their unused product for replacement.

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 10 Bowman Dr, Keene, New Hampshire 03431-5043

Distribution

Distribution pattern: US in the state of FL.

Timeline

Recall initiated: 2014-12-17
Posted by FDA: 2015-01-29
Terminated: 2015-06-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132165. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.