Recall Z-2943-2018— Bard Medical Division
Class II · Terminated
Class II FDA medical device recall by Bard Medical Division, initiated 2018-03-21, terminated 2020-04-02. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Bard Medical Division
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-21
- Terminated
- 2020-04-02
- Firm location
- Covington, GA, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.