FDA Medical Device Recalls (openFDA)
Bard Medical Division: 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.
- Recall number
- Z-2943-2018
- Recalling firm
- Bard Medical Division
- 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.
- Status
- Terminated
- Initiated
- 2018-03-21
- Posted
- not on file
- Terminated
- 2020-04-02
- Reason
- 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.
- Root cause
- 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
- 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,
- Lot, serial or model codes
- Catalog #842802 Lot #'s: NGZF4111, NGZF0382, NGZE0787, NGZD3819, NGZI1126, NGAP2619, NGAT0331, NGAT4059, NGAW1807, and NGBS2822
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMH
- Firm FEI
- 1018233
- Firm city
- Covington
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28