Z-2943-2018Class II

Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I...

Name: Z-2943-2018 Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I...
Creator: Bard Medical Division
Published: 2018-03-21
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2018-03-21 / Terminated

FDA source

Bard Medical Division began a recall of 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... on 2018-03-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2943-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-21
Posted: 2018-08-25
Terminated: 2020-04-02
Recalling firm: C.R. Bard Inc
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.
Product code: FMH Container, Specimen, Sterile
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 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 [email protected] 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,
Product codes and lots: Catalog #842802 Lot #'s: NGZF4111, NGZF0382, NGZE0787, NGZD3819, NGZI1126, NGAP2619, NGAT0331, NGAT4059, NGAW1807, and NGBS2822

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2943-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2943-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-25

Product code FMH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)