Home / Recalls / Cook Inc. / Z-0455-2020

Z-0455-2020 Class II Terminated

Recalled by Cook Inc. — Bloomington, IN

FDA device recall Z-0455-2020 was initiated by Cook Inc. on October 21, 2019 and is designated Class II. Reason for recall: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. The recall status is terminated (terminated June 30, 2020). Affected quantity: 1,679.

Recall Details

Product Type
Devices
Report Date
November 27, 2019
Initiation Date
October 21, 2019
Termination Date
June 30, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,679

Product Description

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Reason for Recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

Code Information

REF (RPN): HNB5.0-38-100-P-NS-DAV REF (GPN): G08895 Lot Numbers: 9693495, 9701375, 9703638, 9703647, 9703648, 9708138, 9708139, 9708140, 9708542, 9709228, 9709932, 9712996, 9715458, 9715462, 9715468, 9715469, 9716505, 9733722, 9734096 UDIs: (01)00827002088955(17)220508(10)9693495, (01)00827002088955(17)220510(10)9701375, (01)00827002088955(17)220510(10)9703638, (01)00827002088955(17)220510(10)9703647, (01)00827002088955(17)220510(10)9703648, (01)00827002088955(17)220513(10)9708138, (01)00827002088955(17)220514(10)9708139, (01)00827002088955(17)220514(10)9708140, (01)00827002088955(17)220513(10)9708542, (01)00827002088955(17)220516(10)9709228, (01)00827002088955(17)220514(10)9709932, (01)00827002088955(17)220516(10)9712996, (01)00827002088955(17)220516(10)9715458, (01)00827002088955(17)220517(10)9715462, (01)00827002088955(17)220516(10)9715468, (01)00827002088955(17)220517(10)9715469, (01)00827002088955(17)220517(10)9716505, (01)00827002088955(17)220524(10)9733722, (01)00827002088955(17)220523(10)9734096

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-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-0594-2021 Class I — Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G5623 (November 24, 2020)
  • Z-0603-2021 Class I — Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G4904 (November 24, 2020)

FDA data resources