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U.S. Department of Health and Human Services

Class 2 Device Recall Welch Allyn Connex Spot Monitor

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  Class 2 Device Recall Welch Allyn Connex Spot Monitor see related information
Date Initiated by Firm August 10, 2023
Date Posted September 12, 2023
Recall Status1 Open3, Classified
Recall Number Z-2581-2023
Recall Event ID 92874
510(K)Number K142356  
Product Classification Monitor, physiological, patient (without arrhythmia detection or alarms) - Product Code MWI
Product Welch Allyn Connex Spot Monitor
Code Information Product Code: 75MT-B; UDI: 00732094209372; Serial Numbers: 100027582923 and 100027862923
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display.
FDA Determined
Cause 2		 Device Design
Action The consignee recall notification was sent out via email 08/10/2023. The letter instructs the consignee to immediately locate, isolate, and cease all use of the affected product, contact Baxter Customer Service and Technical Support to arrange for return and replacement of the impacted units, acknowledge receipt by responding on the customer portal, and notify other affected customers of the consignee. Affected product will be removed from the field and customers will receive replacement units of the Connex Spot Monitor. Impacted product will be returned to Baxter and will be destroyed per the Return Material Authorization process.
Quantity in Commerce 2 units
Distribution US Nationwide distribution in the state of CA.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MWI and Original Applicant = WELCH ALLYN, INC.
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