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U.S. Department of Health and Human Services

Class 2 Device Recall Miniscav

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  Class 2 Device Recall Miniscav see related information
Date Initiated by Firm August 23, 2023
Date Posted September 20, 2023
Recall Status1 Open3, Classified
Recall Number Z-2619-2023
Recall Event ID 92929
510(K)Number K160950  
Product Classification Pump, portable, aspiration (manual or powered) - Product Code BTA
Product MINISCAV (tm) Vacuum Pump
Code Information UDI/DI: (01) 10862552000405. Serial numbers: N/AB/10514 through N/AB/10523
Recalling Firm/
Manufacturer		 R A Medical Services
Holmes House
Skipton Road
Keighley United Kingdom
Manufacturer Reason
for Recall		 Inadequate documentation of acceptance activity
FDA Determined
Cause 2		 Process control
Action R A Medical Services notified the only consignee via email on 08/23/2023. Instructions were to quarantine and return affected units.
Quantity in Commerce 10 units
Distribution Distribution to Ohio
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 = BTA and Original Applicant = Sedation Systems LLC
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