Home / Recalls / Medrad Inc / Z-1586-2013

Z-1586-2013 Class II Terminated

Recalled by Medrad Inc — Indianola, PA

FDA device recall Z-1586-2013 was initiated by Medrad Inc on April 15, 2013 and is designated Class II. Reason for recall: The firm is recalling these power cables due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the cable jacket. The recall status is terminated (terminated April 3, 2014). Affected quantity: 1,066.

Recall Details

Product Type
Devices
Report Date
July 3, 2013
Initiation Date
April 15, 2013
Termination Date
April 3, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,066

Product Description

DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient

Reason for Recall

The firm is recalling these power cables due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the cable jacket.

Distribution Pattern

Worldwide Distribution - US Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of: AE, AU, AZ, BN, BR, CA, CH, CL, CO, DE, DK, DO, DZ, EG, ES, FR, GB, HK, HN, HR, HU, IN, IT, JO, JP, KR, LB, MU, MX, MY, NL, PH, PS, SA, SG, TH, TR, TW, UY, VE, and ZA.

Code Information

Catalog numbers 3011992, 3011992W, 3011993, 3011993W, 3011994, 3011994W, 3011996, 3011996W, 3014268 and 3014268W.

Other recalls by Medrad Inc

  • Z-0870-2013 Class II — MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac c (November 5, 2012)
  • Z-0598-2013 Class II — Medrad(R) Continuum MR Infusion System Primary Set Peristaltic Pump System de (April 18, 2012)
  • Z-0597-2013 Class II — Medrad(R) Continuum MR Infusion System Secondary Administration Kit Peristalt (April 18, 2012)
  • Z-0602-2013 Class II — Medrad(R) Continuum MR Infusion System Secondary Set Peristaltic Pump System (April 18, 2012)
  • Z-0595-2013 Class II — Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for pat (April 18, 2012)
  • Z-0600-2013 Class II — Medrad(R) Continuum MR Infusion System Primary VSA Set Peristaltic Pump Syste (April 18, 2012)
  • Z-0603-2013 Class II — Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump S (April 18, 2012)
  • Z-0601-2013 Class II — Medrad(R) Continuum MR Infusion System Primary Spike Set Peristaltic Pump Sys (April 18, 2012)
  • Z-0605-2013 Class II — Medrad(R) Continuum MR Infusion System Side Step Set Peristaltic Pump System (April 18, 2012)
  • Z-0596-2013 Class II — Medrad(R) Continuum MR Infusion System Standard Administration Kit Peristalti (April 18, 2012)

FDA data resources