Recall Z-1443-2014 ยท LGZ Warmer, Thermal, Infusion Fluid
Smiths Medical ASD, Inc.
Smiths Medical HOTLINE Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
| Date | Apr 9, 2014 (initiated Mar 17, 2014) |
| Status | Terminated |
| Reason | 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 | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 393,210 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911383 | HOTLINE FLUID WARMER Level 1 Technologies, Inc., Oct 17, 1991 |