Home / Recalls / Cook Inc. / Z-0589-2020

Z-0589-2020 Class I Terminated

Recalled by Cook Inc. — Bloomington, IN

Recall Details

Product Type
Devices
Report Date
December 18, 2019
Initiation Date
November 8, 2019
Termination Date
February 1, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
43

Product Description

CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.

Reason for Recall

A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).

Distribution Pattern

Distribution to US states of AL, CA, CT, FL, GA, IL, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, and VA, and Brazil.

Code Information

Lot Numbers 9945301, 9953512 UDI: (01)00827002515833(17)221308(10)9945301 UDI: (01)00827002515833(17)221608(10)9953512

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-0223-2022 Class II — Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxi (October 8, 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-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-0610-2021 Class I — Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-S (November 24, 2020)
  • Z-0594-2021 Class I — Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G5623 (November 24, 2020)