NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-INT-230. Product Usage: NORMOFL

FDA device recall Z-1105-2017 · posted 2017-01-26 · Terminated

Recall details

Recalling firm

Smiths Medical ASD, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

LHC

Quantity affected

1

Distribution

Distribution in the foreign country of Sweden

Date initiated

2016-10-25

Date posted

2017-01-26

Date terminated

2017-07-25

Location

Saint Paul, MN