Recalls / —
—#126134
Product
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
- FDA product code
- LGZ — Warmer, Thermal, Infusion Fluid
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K911383
- Affected lot / code info
- 2513261 2531612 2540540 2545044 2588656
Why it was recalled
Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Smiths Medical ASD, Inc.
- Address
- 160 Weymouth St, Rockland, Massachusetts 02370-1136
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2014-03-17
- Posted by FDA
- 2014-04-09
- Terminated
- 2015-06-09
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #126134. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.