Recall Z-1028-2015 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Smiths Medical ASD, Inc.
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).
| Date | Jan 29, 2015 (initiated Dec 17, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Employee error |
| Action | 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. |
| Quantity | 900 units |
| Distribution | US in the state of FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952516 | PRO-VENT, LINE DRAW, PULSATOR Smiths Industries Medical Systems, Inc., Jul 14, 1995 |