Smiths Medical HOTLINE Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous
FDA device recall Z-1444-2014 · posted 2014-04-09 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged
- Action taken
- Smiths Medical issued Urgent Field Safety Notice Recall on 3/17/14 via mail service. Distributors will be instructed to notify their customers. The Field Safety Notice will also include an Urgent Recall Notice Confirmation Form (Confirmation Form) that consignees will be instructed to send back to Smiths Medical for carrying out the action and tracking effectiveness.Accounts are to inspect inventory and return recalled product. If you should have any questions regarding this information, please contact Shirley Duggan, Quality System Engineer at 1-781-763-9335 or by E-Mail Shirley.duggan@smiths-medical.com.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LGZ
- Quantity affected
- 870 units
- Distribution
- Worldwide Distribution - USA Nationwide in the states of: AU, CA, CL, CN, CZ, GT, ID, IN, IT, JP, LY, NZ, QA, SG, SK, TR, TW.
- Date initiated
- 2014-03-17
- Date posted
- 2014-04-09
- Date terminated
- 2015-06-09
- Location
- Rockland, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOTLINE FLUID WARMER (K911383) | Level 1 Technologies, Inc. | 1991-10-17 |