FDA Device recall Z-0607-2021
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introducers and Guiding Sheaths are intended to in…
- FDA Device
- Class I
- terminated
- Published 2020-12-30
On 2020-12-30 the FDA classified a Class I recall of Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introducers and Guiding Sheaths are intended to in… by Cook, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0607-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-11-24 |
| Published | 2020-12-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cook |
| Distribution | US |
Product
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Reason
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.
Identifiers
| code_info | Lot Numbers: 13105055, 13124400, 13124401, 13135880, 13138926, 13140911, 13141335, 13162741, 13162742, 13168155, 131681…Lot Numbers: 13105055, 13124400, 13124401, 13135880, 13138926, 13140911, 13141335, 13162741, 13162742, 13168155, 13168156, 13170665, 13189283, 13214450, 13214451, 13214452, 13214455, 13221812, 13231810, 13237657, 13249434, 13252354, 13252362, 13262332, 13288118, 13291868, 13294511, 13307182, 13315176, 13337784, 13337785, 13337786, 13346090, 13354241, 13357216, 13360416, 13366208, 13366240, 13380385, 13388332 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0607-2021%22
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