Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall NORMOFLO H1100 Irrigation Fluid Warmers

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall NORMOFLO H1100 Irrigation Fluid Warmers see related information
Date Initiated by Firm October 25, 2016
Date Posted January 26, 2017
Recall Status1 Terminated 3 on July 25, 2017
Recall Number Z-1105-2017
Recall Event ID 76190
Product Classification Warmer, irrigation solution - Product Code LHC
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.
Code Information S105B0061
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
For Additional Information Contact Smiths Medical Representative
651-633-2556
Manufacturer 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.
FDA Determined
Cause 2		 Labeling mix-ups
Action 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.
Quantity in Commerce 1
Distribution Distribution in the foreign country of Sweden
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-