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
Reported: April 16, 2014 Initiated: March 17, 2014 #Z-1444-2014
Product Description
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
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
Details
- Recalling Firm
- Smiths Medical ASD, Inc.
- Units 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.
- Location
- Rockland, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Smiths Medical ASD, Inc.. Units affected: 870 units.
Why was this product recalled? ▼
Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 16, 2014. Severity: Moderate. Recall number: Z-1444-2014.
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