Home / Recalls / Cook Inc. / Z-1870-2017

Z-1870-2017 Class II Terminated

Recalled by Cook Inc. — Bloomington, IN

Recall Details

Product Type
Devices
Report Date
April 26, 2017
Initiation Date
March 7, 2017
Termination Date
October 16, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19756

Product Description

Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set

Reason for Recall

Product may overheat, melt, and burn patient.

Distribution Pattern

The devices have been distributed within the United States and the following countries: Bahamas, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Ireland, Israel, Italy, Jersey, Kuwait, Mexico, Morocco, New Zealand, Norway, Panama, Paraguay, Portugal, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Trinidad and Tobago, United Arab Emirates and the United Kingdom.

Code Information

All lots.

Other recalls by Cook Inc.

  • Z-0388-2022 Class II — Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45- (November 12, 2021)
  • Z-0387-2022 Class II — Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45 (November 12, 2021)
  • Z-0414-2022 Class II — Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigi (October 13, 2021)
  • Z-0222-2022 Class II — Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. (October 8, 2021)
  • Z-0223-2022 Class II — Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxi (October 8, 2021)
  • Z-0186-2022 Class II — Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-3 (September 28, 2021)
  • Z-0185-2022 Class II — Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 (September 28, 2021)
  • Z-0960-2021 Class II — Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retr (January 4, 2021)
  • Z-0604-2021 Class I — Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G5622 (November 24, 2020)
  • Z-0600-2021 Class I — Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G5622 (November 24, 2020)