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.
FDA Recall Z-2943-2018 · Posted None
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Recalling FirmBard Medical Division
Recall StatusTerminated
Product CodeFMH
Date Initiated2018-03-21
Date Terminated2020-04-02
Product Quantity131,950
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.
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 #).
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
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,
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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