FDA Device recall Z-0751-2021
Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev
- FDA Device
- Class II
- terminated
- Published 2021-01-06
On 2021-01-06 the FDA classified a Class II recall of Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev 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-0751-2021 |
| 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
Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105 For Angiography/angioplasty. The contents of the kit are surgical drapes, gowns, towels, medicine cups, needles, various bowls, pen and label set (PAL), scalpel, several syringes, chloraprep, table cover, and gauze to be used in a Cardiac Cath procedure.
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)00884450515105 Lot # T1907711, |
|---|
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-0751-2021%22
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