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U.S. Department of Health and Human Services

Class 2 Device Recall BARD Magic3 GO

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 Class 2 Device Recall BARD Magic3 GOsee related information
Date Initiated by FirmApril 20, 2023
Date PostedJune 08, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1700-2023
Recall Event ID 92082
510(K)NumberK172247 
Product Classification Catheter, straight - Product Code EZD
ProductMagic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G
Code Information a) REF 52810G, UDI/DI 00801741136870, Lot Numbers: JUGW1445
FEI Number 1018233
Recalling Firm/
Manufacturer		 C.R. Bard Inc
8195 Industrial Blvd Ne
Covington GA 30014-1497
For Additional Information Contact
770-784-6100
Manufacturer Reason
for Recall		Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe firm issued an URGENT MEDICAL DEVICE RECALL to its consignee beginning on 04/20/2023 by Fed Ex and email. The notice explained the problem, risk, and requested the following actions be taken: Discontinue distribution of the product and dispose of all affected product, Distributors are directed to notify their customers. For further assistance please contact: 1-844-8BD- LIFE (1-844-823-5433) Say "Recall" when prompted; M-F 8am - 5pm CT
Quantity in Commerce5760 devices
DistributionWorldwide
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 = EZD
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