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U.S. Department of Health and Human Services

Class 3 Device Recall SureStep Tray, with AddaFoley

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  Class 3 Device Recall SureStep Tray, with AddaFoley see related information
Date Initiated by Firm June 29, 2016
Create Date August 03, 2016
Recall Status1 Terminated 3 on December 05, 2017
Recall Number Z-2333-2016
Recall Event ID 74610
Product Classification Collector, urine, (and accessories) for indwelling catheter - Product Code KNX
Product SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization
The product is a urine collection system that includes a STATLOCK Foley Stabilization Device
Code Information Lot Number NGZG1722
Recalling Firm/
Manufacturer
C.R. Bard, Inc.
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information Contact Jeff DeSanty
401-825-8690
Manufacturer Reason
for Recall
Labeling problem
FDA Determined
Cause 2
Labeling mix-ups
Action Bard Medical sent an Urgent Medical Device Product Recall letter dated June 29, 2016. The letter identified the product, the problem, and the action to be taken by the customer. The letter requested that customers examine their inventory and quarantine the product. The letter also requested a sub-recall. The letter included a reply form which is to be returned to Bard. Customers were also instructed if product was further distributed they identify customers and notify them at once. Customers with questions should contact the BMD Recall Coordinator at 1-800-793-8110.
Quantity in Commerce 530 units
Distribution Nationwide Distribution to CA, FL, IL, IA, KY, NC, MN, NC, OR, RI, SD, TX, UT, and WA.
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.
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