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U.S. Department of Health and Human Services

Class 2 Device Recall SureStep Foley Tray System

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  Class 2 Device Recall SureStep Foley Tray System see related information
Date Initiated by Firm August 05, 2021
Date Posted September 23, 2021
Recall Status1 Open3, Classified
Recall Number Z-2530-2021
Recall Event ID 88499
510(K)Number K910846  
Product Classification Foley Catheter Kit - Product Code EZC
Product Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Code Information Catalog A800360, Lot NGFR3570, UDI (01)00801741073922(17)251228(10)
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		 There is potential for packaging defects that may impact the sterile barrier.
FDA Determined
Cause 2		 Packaging change control
Action Customer letters were sent "URGENT MEDICAL DEVICE RECALL" via FedEx and email to affected consignees on August 13, 2021. Customers are asked to please Take the Following Actions: 1. Note that there may be a supply disruption in Foley catheter trays from all sources due to the current product shortage driven by this issue and other issues with third party Foley manufacturers. 2. Please check all inventory locations within your institution for the specific catalog and lot number combinations listed in Attachment 1 of this recall notice. 3. Share this recall notice with any users of the product, within your facilities, to ensure they are also aware of this recall notice. 4. If you purchased this product from a distributor, contact your distributor for further instructions. 5. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the notification, whether or not you have any affected product, so that BD may acknowledge your receipt of this notification and process any applicable order credit. 6. Report any adverse health consequences experienced with the use of this product to BD at the contact information below. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program BD will process order credits, including shipping costs, for all customers discontinuing use of and returning product as a result of this notification, following receipt of the completed Customer Response Form. BD has implemented actions to prevent recurrence of this product issue. The firm, BD, sent an updated letter dated October 8, 2021 informing customers of additional affected lot numbers that were distributed between March 2021 through July 23, 2021.
Quantity in Commerce 1140 units
Distribution US Nationwide 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 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 = EZC and Original Applicant = C.R. BARD, INC.
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