Merit Medical Systems, Inc. Recall: Product Code: K05T-02533, Custom Inflation Kit, Custom
Merit Medical Systems, Inc. Recall: Product Code: K05T-02533, Custom Inflation Kit, Custom is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Merit Medical Systems, Inc.; Product: Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiog
| Recalling firm | Merit Medical Systems, Inc. |
|---|---|
| Product | 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 |
| Reason for recall | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | US distribution to: KY, RI, and MD |
| Recall initiated | 20201110 |
| Recall number | Z-0749-2021 |
| Category | device |
| State | UT |
| Country | United States |
$29/mo
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