Home / Recalls / Cook Inc. / Z-0598-2021

Z-0598-2021 Class I Terminated

Recalled by Cook Inc. — Bloomington, IN

FDA device recall Z-0598-2021 was initiated by Cook Inc. on Nov 24, 2020 and is designated Class I. Reason for recall: There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential… The recall status is terminated (terminated Sep 7, 2022). Affected quantity: 9768.

Recall Details

Product Type
Devices
Report Date
Dec 30, 2020
Initiation Date
Nov 24, 2020
Termination Date
Sep 7, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9768

Product Description

Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Reason for Recall

There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.

Distribution Pattern

US Nationwide Distribution including states of: AK, CT, IA, LA, MO, NH, OK, TN, WI, AL, DC, ID, MA, MS, NJ, OR, TX, WV, AR, DE, IL, MD, MT, NM, PA, UT, WY, AZ, FL, IN, ME, NC, NV, RI, VA, CA, GA, KS, MI, ND, NY, SC, VT, CO, HI, KY, MN, NE, OH, SD, WA and Global Distribution to: AU, SG, Austria, Belgium, Canary Islands, CN, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, KR, Latvia, Lithuania, MY, Morocco, Netherlands, Norway, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, TW, TH, and United Arabs Emirates.

Code Information

Lot Numbers: 13135825, 13138939, 13138940, 13143095, 13143096, 13143097, 13150435, 13150438, 13150439, 13150440, 13150441, 13153382, 13153386, 13153387, 13155287, 13155288, 13155295, 13155296, 13158205, 13159698, 13159699, 13159701, 13159702, 13159703, 13159704, 13159705, 13166156, 13166160, 13166161, 13166162, 13172674, 13172679, 13172680, 13172681, 13175467, 13175468, 13175472, 13180819, 13186324, 13186325, 13186326, 13186329, 13186331, 13189188, 13189189, 13189190, 13189195, 13189196, 13189197, 13192073, 13197482, 13200417, 13200418, 13202955, 13202956, 13205308, 13207461, 13207462, 13207463, 13207464, 13211828, 13214464, 13214465, 13217129, 13217132, 13217133, 13217134, 13217135, 13217136, 13217137, 13221800, 13221806, 13221807, 13226796, 13226797, 13226798, 13226799, 13226800, 13226801, 13231821, 13237671, 13237672, 13240020, 13240021, 13240022, 13240023, 13240024, 13240025, 13246564, 13246565, 13256701, 13256707, 13256708, 13256709, 13256710, 13256711, 13262346, 13262347, 13268037, 13281553, 13281792, 13281793, 13281794, 13281795, 13281796, 13281797, 13281798, 13281799, 13291872, 13291875, 13294539, 13294540, 13294541, 13294542, 13297253, 13297254, 13297255, 13297256, 13297257, 13301868, 13301869, 13301870, 13304446, 13307201, 13307202, 13307203, 13307204, 13310756, 13310757, 13310758, 13312696, 13312701, 13312702, 13312703, 13315213, 13315214, 13315215, 13315216, 13318057, 13318058, 13320584, 13320592, 13320593, 13329231, 13329243, 13329244, 13329245, 13329247, 13332165, 13332166, 13334765, 13334766, 13334772, 13342864, 13342865, 13342866, 13346103, 13346104, 13346117, 13349025, 13349035, 13349036, 13352476, 13352477, 13352478, 13352479, 13352480, 13352481, 13352482, 13352483, 13357255, 13357256, 13360433, 13360434, 13360435, 13360436, 13360437, 13360439, 13366224, 13366225, 13372603, 13372604, 13375216, 13375217, 13375218, 13375219, 13375220, 13376996, 13380383, 13382713, 13382714, 13382715, 13382716, 13388322, 13388323, 13388324, 13391160, 13398852, 13423953, 13432833, 13446739, 13446740, 13455461, 13334771X

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0598-2021
openFDA file date
Oct 6, 2026
Loaded by RegDataLab
Oct 12, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it. FDA may have changed the recall since.

Other recalls by Cook Inc.

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  • Z-0387-2022 Class II — Flexor Check-Flo Introducer Ansel Modification Model Number… (Nov 12, 2021)
  • Z-0414-2022 Class II — Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290… (Oct 13, 2021)
  • Z-0222-2022 Class II — Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365… (Oct 8, 2021)
  • Z-0223-2022 Class II — Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261… (Oct 8, 2021)
  • Z-0186-2022 Class II — Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN… (Sep 28, 2021)
  • Z-0185-2022 Class II — Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908… (Sep 28, 2021)
  • Z-0960-2021 Class II — Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for… (Jan 4, 2021)
  • Z-0600-2021 Class I — Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number… (Nov 24, 2020)
  • Z-0610-2021 Class I — Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN… (Nov 24, 2020)

FDA data resources