Recall Z-1028-2015— Smiths Medical ASD, Inc.
Class III · Terminated
Class III FDA medical device recall by Smiths Medical ASD, Inc., initiated 2014-12-17, terminated 2015-06-25. It names one FDA 510(k) clearance: K952516. 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).. 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..
- Recalling firm
- Smiths Medical ASD, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2014-12-17
- Terminated
- 2015-06-25
- Firm location
- Keene, NH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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).
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.