Smiths Medical HOTLINE Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
This recall has been terminated (originally issued April 9, 2014).
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- March 17, 2014
- Posted
- April 9, 2014
- Terminated
- June 9, 2015
- Recall Number
- Z-1444-2014
- Quantity
- 870 units
- Firm Location
- Rockland, MA
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
2513261 2531612 2540540 2545044 2588656
Root Cause
Nonconforming Material/Component
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.