Covington, GA, United States
Bard Medical Division recalls
5 recalls recorded since 2018, most recently on 13 December 2018. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)1
Terminated or completed4
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 13 December 2018
- Terminated
- 2 November 2020
- Reason
- potential for urine leakage around the vent on the vented sample port
- Distribution
- US, Canada, UAE
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0803-2019
- SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A303414A, A303416A, A3034
Ongoing Class II Medical devices
- Recall started
- 6 December 2018
- Reason
- Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the vent on the sample port.
- Distribution
- US Nationwide Distribution io KY, NE, GA, FL, MS, IN, IL, VA, OK, TX, NM, IL, VA, PA, CA, NV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0800-2019
- BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for use in the drainage an
Terminated Class II Medical devices
- Recall started
- 13 June 2018
- Terminated
- 16 February 2021
- Reason
- An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system.
- Distribution
- Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL,GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Worldwide Distribution: Canada, Austria, Bahrain, Belgium, Brazil, B
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2536-2018
- Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a non-invasive, thermal regulating system, indicated for monitoring and controlling patient temperature within a range of 32¿C to 38
Terminated Class II Medical devices
- Recall started
- 21 March 2018
- Terminated
- 2 April 2020
- 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.
- 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,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2943-2018
- 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
Terminated Class II Medical devices
- Recall started
- 8 November 2017
- Terminated
- 2 September 2020
- Reason
- Specific lots of ArcticGel Pads have potential issues which may result in the insufficient adhesion of the hydrogel to the pad.
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Argentina, Australia, Canada, Saudi Arabia, South Korea, Singapore, Thailand, and Chile
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1241-2019
- Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium Pad Kit, 31707I c) Intrepid ArcticGel Large Pad Kit, 31709I d) Intr
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.