FDA Device recall Z-0749-2021
Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty
- FDA Device
- Class II
- terminated
- Published 2021-01-06
On 2021-01-06 the FDA classified a Class II recall of Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty by Merit Medical Systems, citing 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 dev….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0749-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-10 |
| Published | 2021-01-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Merit Medical Systems |
| Distribution | KY, MD, RI |
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
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.
Identifiers
| code_info | (01)00884450255803 Lot # T1883210 |
|---|
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-0749-2021%22
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