CLASS II Device recall · Reported 5 Sep 2018 · FDA Enforcement Report

Bard Midstream Urine Collector with Rigid Funnel recalled

Bard Medical Division is recalling Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads, distributed in 24 states. The recall was initiated on 21 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog #842802 Lot #'s: NGZF4111, NGZF0382, NGZE0787, NGZD3819, NGZI1126, NGAP2619, NGAT0331, NGAT4059, NGAW1807, and NGBS2822

Quantity recalled131,950

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2943-2018
FDA event ID: 80624
Recalling firm: Bard Medical Division, Covington, GA
Classification: Class II
Status: Terminated
Recall initiated: 21 Mar 2018
FDA classified: 25 Aug 2018
Reported: 5 Sep 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

21 Mar 2018	Recall initiated by company
25 Aug 2018	Classified by FDA	+157 days
5 Sep 2018	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

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,

Arkansas California Colorado Florida Georgia Iowa Illinois Indiana Kansas Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi North Carolina New Jersey New York South Carolina

Questions about this recall

Is Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads recalled?

Yes. Bard Medical Division recalled Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads on 21 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-2943-2018.

Why was it recalled?

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.

Which lots are affected?

Catalog #842802 Lot #'s: NGZF4111, NGZF0382, NGZE0787, NGZD3819, NGZI1126, NGAP2619, NGAT0331, NGAT4059, NGAW1807, and NGBS2822

Where was it sold?

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,

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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