Bard Midstream Urine Collector Recalled for Iodine Prep Pad Deficiency
Bard Medical Division is recalling 131,950 urine collection kits because the included iodine prep pads failed to meet required assay levels for their expiration dating.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a failure to meet assay requirements for expiration dating without reporting any specific injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or labeling/quality control issues where harm has not been reported.
Plain-English summary
Bard Medical Division is recalling 131,950 units of Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. The recall was initiated after Medline notified Bard Medical Division that the Aplicare Povidone Iodine (PVP-I) Prep Pads included in the kits were not meeting the iodine assay level requirements necessary to support the 36-month expiration dating.
The affected products are identified by Catalog #842802 and include lots NGZF4111, NGZF0382, NGZE0787, NGZD3819, NGZI1126, NGAP2619, NGAT0331, NGAT4059, NGAW1807, and NGBS2822. Each kit carton contains three PVP-I prep pads, a pre-connected drainage funnel, a specimen container, a funnel lid, a specimen lid, and a room label.
The products were distributed in the following states: 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. Healthcare facilities and consumers should stop using the affected lots and contact Bard Medical Division for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- Bard Medical Division
- Affected units
- 131,950
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Catalog #842802 Lot #'s: NGZF4111
- NGZF0382
- NGZE0787
- NGZD3819
- NGZI1126
- NGAP2619
- NGAT0331
- NGAT4059
- NGAW1807
- and NGBS2822
Distribution
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