Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Nu
FDA device recall Z-1028-2015 · posted 2015-01-29 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 900 units
- Distribution
- US in the state of FL.
- Date initiated
- 2014-12-17
- Date posted
- 2015-01-29
- Date terminated
- 2015-06-25
- Location
- Keene, NH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRO-VENT, LINE DRAW, PULSATOR (K952516) | Smiths Industries Medical Systems, Inc. | 1995-07-14 |