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Terminated

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 Recall Z-1444-2014 · Posted 2014-04-09

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeLGZ
Date Initiated2014-03-17
Date Terminated2015-06-09
Product Quantity870 units

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

Firm 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 [email protected].

Root Cause

Nonconforming Material/Component

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K911383HOTLINE FLUID WARMERLevel 1 Technologies, Inc. · 1991-10-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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