Home / Recalls / Cook Inc. / Z-0960-2021

Z-0960-2021 Class II Terminated

Recalled by Cook Inc. — Bloomington, IN

Recall Details

Product Type
Devices
Report Date
February 17, 2021
Initiation Date
January 4, 2021
Termination Date
September 16, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
42 units

Product Description

Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent Reference Part Number (RPN): 003700 GPN: G14837

Reason for Recall

Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation.

Distribution Pattern

FL, KY, MD, NS, NY, PA, TX Foreign: Canada, Switzerland

Code Information

Lot Numbers: 13024536 13089895 NS13089897 UDI: (01)00827002148376(17)230303(10)13024536 (01)00827002148376(17)230327(10)13089895 (01)00827002148376(17)230327(10)NS13089897

Other recalls by Cook Inc.

  • Z-0387-2022 Class II — Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45 (November 12, 2021)
  • Z-0388-2022 Class II — Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45- (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-0185-2022 Class II — Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 (September 28, 2021)
  • Z-0186-2022 Class II — Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-3 (September 28, 2021)
  • Z-0598-2021 Class I — Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G5623 (November 24, 2020)
  • Z-0596-2021 Class I — Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G5622 (November 24, 2020)
  • Z-0604-2021 Class I — Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G5622 (November 24, 2020)