Product Code: K05T-02533 — Class II medical device recall Z-0749-2021
Terminated recall by Merit Medical Systems, Inc., reported 2021-01-06, distributed in KY, MD, RI. Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromi
| Recall number | Z-0749-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2020-11-10 |
| Classified | 2020-12-29 |
| Reported by FDA | 2021-01-06 |
| Terminated | 2022-10-05 |
| Distributed | KY, MD, RI |
| Quantity | 90 kits |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00884450255803 |
| Lot numbers | T1883210 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0749-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.