Merit Medical Systems, Inc. Recall 86831
Description: Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups, needles, various bowls, pen and label sets (PAL), scalpel, several syringes, table covers, stopcocks, inflation device, and gauze
Merit Medical Systems, Inc. Recall 86831 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0749-2021 |
| Event ID | 86831 |
| Event Description | Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups, needles, various bowls, pen and label sets (PAL), scalpel, several syringes, table covers, stopcocks, inflation device, and gauze |
| Product Type | Devices |
| Distribution | US distribution to: KY, RI, and MD |
| Quantity | 90 kits |
| Recall Reason | Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which may lead to an infection requiring medical treatment. |
| Device Classification | 20210106 |
| Device Code Info | (01)00884450255803 Lot # T1883210 |
| Center Classification Date | 20201229 |
| Recall Initiation Date | 20201110 |
| Recalling Firm | Merit Medical Systems, Inc. |
| Initial Notification | Letter |
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