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U.S. Department of Health and Human Services

Class 2 Device Recall Vygon

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  Class 2 Device Recall Vygon see related information
Date Initiated by Firm October 03, 2017
Create Date March 09, 2018
Recall Status1 Terminated 3 on January 06, 2020
Recall Number Z-0933-2018
Recall Event ID 79318
510(K)Number K882503  
Product Classification I.V. start kit - Product Code LRS
Product Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF.

Kit used when administering IV during emergency.
Code Information AMS-623T-6 (1506075D, 1508057D, 1511030D, 1604024D, 1605080D, 1610017D, 1706097D, 1707055D) and AMS-626TGSLF (1601102D, 1603099D, 160581D, 1607019D, 1610057D, 1703068D, 1703069D, 1704065d, 1706076D, 1707031d, 1707056D)
Recalling Firm/
Manufacturer		 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
87 Venture Dr
Dover NH 03820-5914
Manufacturer Reason
for Recall		 The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting iodine assay level requirements to support the 36 month expiration date. All kits containing the affected pads were recalled.
FDA Determined
Cause 2		 Under Investigation by firm
Action Vygon sent an Urgent Medical Device Recall letter dated October 3, 2017. Customers requested to check stock and quarantine affected devices and to complete Recall Acknowledgement and Inventory Return Form. Customers instructed to fax or email the form to Vygon including customer contact info. Vygon will contact the customer and issue a Return Merchandise Authorization Number. Distributors instructed to communicate recall to customers who received affected product and provide them copy of the recall notification. Returned products were received in Lansdale, PA warehouse location and placed into quarantine. For further questions, please call Customer Service at (800) 473-5414.
Quantity in Commerce 21350
Distribution US Distribution.
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.
510(K) Database 510(K)s with Product Code = LRS and Original Applicant = CHURCHILL MEDICAL SYSTEMS, INC.
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