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U.S. Department of Health and Human Services

Class 2 Device Recall Bard CleanCath Intermittent Catheter

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 Class 2 Device Recall Bard CleanCath Intermittent Cathetersee related information
Date Initiated by FirmJanuary 11, 2021
Create DateApril 16, 2021
Recall Status1 Terminated 3 on February 02, 2023
Recall NumberZ-1431-2021
Recall Event ID 87163
510(K)NumberK802665 
Product Classification Catheter, urological - Product Code KOD
ProductBard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.
Code Information Cat. No. 420712/Lot No. NGDY1813/ UDI (GTIN) (01)00801741038730(17)241130(10), Exp. Date 11/30/2024
FEI Number 1018233
Recalling Firm/
Manufacturer		 C.R. Bard, Inc.
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information ContactMs. Gail Griffiths
770-784-6100
Manufacturer Reason
for Recall		The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.
FDA Determined
Cause 2		Packaging process control
ActionAll customers will be contacted via letters sent via Fed Ex. The acknowledgement form included with the letter that is mailed or faxed back to BD will be reconciled with the customer list. BD will contact 100% of our customers that have not responded to the communication to verify acknowledgement. BD is requesting that customers discard affected components.
Quantity in Commerce9,800 Units
DistributionWorldwide distribution - US Nationwide distribution and the countries of Australia, Canada.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KOD
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