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U.S. Department of Health and Human Services

Class 3 Device Recall VS Cap

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 Class 3 Device Recall VS Capsee related information
Date Initiated by FirmJanuary 20, 2023
Date PostedFebruary 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1357-2026
Recall Event ID 98292
510(K)NumberK201887 
Product Classification Oximeter - Product Code DQA
ProductSurepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
Code Information DI Number: 05060550650013/Lot: 13816/00001 13817/00001 13818/00001 13819/00001 13820/00001 13821/00001 13822/00001 13823/00001 13824/00001 13825/00001 13826/00001 13827/00001 13828/00001 13829/00001 13830/00001 13831/00001 13832/00001 13833/00001 13834/00001 13835/00001 13836/00001 13837/00001 13838/00001 13839/00001 13840/00001
FEI Number 3018685978
Recalling Firm/
Manufacturer		 SUREPULSE MEDICAL LTD
Medicity D6 Thane Road
Nottingham United Kingdom
For Additional Information ContactDr. James Carpenter
+447947239430
Manufacturer Reason
for Recall		Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
FDA Determined
Cause 2		Labeling Change Control
ActionOn January 13, 2023, Surepulse issued a recall notification to affected consignees. Surepulse asked consignees to take the following actions: 1. Attach the notice to the box where the VS Caps are stored or return the VS Caps to SurePulse for adjustment to the label. 2. Acknowledge receipt of the notification.
DistributionWorldwide - US Nationwide distribution in the states of CT, TX and the countries of United Kingdom of Great Britain and Northern Ireland, Netherlands, United Arab Emirates.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DQA
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