Home / Recalls / Cook Inc. / Z-0957-2018

Z-0957-2018 Class II Terminated

Recalled by Cook Inc. — Bloomington, IN

Recall Details

Product Type
Devices
Report Date
March 21, 2018
Initiation Date
October 13, 2017
Termination Date
October 23, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,210

Product Description

Fixed Core Bentson

Reason for Recall

Label does not state that the product is heparin-coated.

Distribution Pattern

Nationally

Code Information

Catalog # TSCFB-/-BH Affected lots range from: F3734676 - F4911986 NS4938980 - NS6144078

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  • 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)
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  • 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)