Cook Inc. Recall 89072
Description: Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Cook Inc. Recall 89072 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0388-2022 |
| Event ID | 89072 |
| Event Description | Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. |
| Product Type | Devices |
| Distribution | AL, AZ, CA, FL, GA, KS, MI, MO, MN, NC, NY, OK, TX Foreign: BE, CH, DE, ES, FR, GB,GU, IT, ZA |
| Quantity | 47 units |
| Recall Reason | Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa |
| Device Classification | 20211222 |
| Device Code Info | Lot Number: 13911710 UDI: (01)00827002441552(17)240422(10)13911710 |
| Center Classification Date | 20211216 |
| Recall Initiation Date | 20211112 |
| Recalling Firm | Cook Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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