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U.S. Department of Health and Human Services

Class 2 Device Recall Urine Collection BARD Midstream Catch Kit with Funnel Connector

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  Class 2 Device Recall Urine Collection BARD Midstream Catch Kit with Funnel Connector see related information
Date Initiated by Firm March 21, 2018
Create Date August 25, 2018
Recall Status1 Terminated 3 on April 02, 2020
Recall Number Z-2943-2018
Recall Event ID 80624
Product Classification Container, specimen, sterile - Product Code FMH
Product Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I prep pads are packed into each urine collection kit carton along with a pre-connected drainage funnel, specimen container, funnel lid, specimen lid and a room label.
Code Information Catalog #842802 Lot #'s: NGZF4111, NGZF0382, NGZE0787, NGZD3819, NGZI1126, NGAP2619, NGAT0331, NGAT4059, NGAW1807, and NGBS2822 
Recalling Firm/
Manufacturer		 Bard Medical Division
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information Contact Recall Coordinator
800-793-8110
Manufacturer Reason
for Recall		 Medline notified BMD that the Aplicare Povidone Iodine (PVP-I) Prep Pads were not meeting the iodine assay level requirements to support 36 month expiration dating.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action On March 21, 2018 Bard medical Division sent all their customers a recall letter with the following instructions: "Immediately examine your inventory and quarantine product subject to this recall. Please refer to the affected reorder number / lot list in Attachment 1 to help you locate the product. Do not use or further distribute any affected product. "Please complete and return the accompanying Recall & Effectiveness Check Form attached to this letter regardless of whether or not you have any of the affected products. Additional instructions for product return are contained on the form. "If you have further distributed any units from the affected lots, please identify your customers / end users and notify them at once of this product recall by forwarding a copy of this letter. Your notification should include a copy of the this notification and the accompanying enclosures If you have affected product, please contact the Recall Coordinator via phone at 1-800-793-8110 or email BMD.FieldAction@crbard.com to obtain a recall authorization number (RCL #).
Quantity in Commerce 131,950
Distribution AR, CA, CO, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, SC, TN, 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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