—#152491

Product

NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-INT-230. Product Usage: NORMOFLO H-1100 Irrigation Fluid Warmers has been designed for safe, in-line warming of irrigating fluids as they are administered to patients. The Fluid Warmer utilizes a solution reservoir housed in a controller unit (warmer). The recirculation solution is heated to present temperature in the reservoir, pumped though a heat exchanger ( a component of the Sets) and is returned to the reservoir for continuous recirculation. The NORMOFLO Warming products are typically used in clinical situations that may require rapid irrigation with warmed fluids.

FDA product code: LHC — Warmer, Irrigation Solution
Device class: Class 1
Medical specialty: Physical Medicine
Affected lot / code info: S105B0061

Why it was recalled

Smiths Medical became aware that that one (1) NORMOFLO H-1100 Irrigation Fluid Warmers was incorrectly labelled with Spanish language labels instead of English labels. Specifically five (5) labels were incorrect; the Operators Manual, Outer Base Box label, Pole Assembly Box label, and two (2) O-ring Lube labels.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Consignee were hand delivered a Smiths Medical Urgent Medical device Filed Safety Notice letter dated October 25, 2016. The letter described the Reason for Field Corrective Action, Risk to Health, and Instructions to Customers. Advised consignees to Provide the device to the Smiths Medical Representative who delivered this notice to you. The Smiths Medical Representative will replace the labeling on the device and packaging, and provide you with the correct English language Operators Manual. Complete the Recall Confirmation Form and return it to Smith Medical via e-mail to FCA.Response@Smiths-medical.com. For questions regarding this notification, please ask the Smiths Medical Representative who delivered the notification or contact Smiths Medical Customer Service Department at +46 859477250.

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 1265 Grey Fox Rd, Saint Paul, Minnesota 55112-6929

Distribution

Distribution pattern: Distribution in the foreign country of Sweden

Timeline

Recall initiated: 2016-10-25
Posted by FDA: 2017-01-26
Terminated: 2017-07-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152491. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.