FDA Device recall Z-0668-2024
PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS
- FDA Device
- Class II
- ongoing
- Published 2024-01-17
On 2024-01-17 the FDA classified a Class II recall of PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS by Baxter Healthcare, citing cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the prod….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0668-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-06 |
| Published | 2024-01-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8 CM US, TS; d) SPG0814: 8 X 14 CM US, TS; e) PC1016SNBIO: 10X16 CM US; f) PC0404SNBIO: 4X4 CM US; g) PC0608SNBIO: 6X8 CM US; h) PC0814SNBIO: 8X14 CM US
Reason
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
Identifiers
| code_info | a) SPG1016: UDI/DI 85412818429, b) SPG0404: UDI/DI 85412818672, c) SPG0608: UDI/DI 85412818313, d) SPG0814: UDI/DI 8…a) SPG1016: UDI/DI 85412818429, b) SPG0404: UDI/DI 85412818672, c) SPG0608: UDI/DI 85412818313, d) SPG0814: UDI/DI 85412818375, e) PC1016SNBIO: UDI/DI 85412530710, f) PC0404SNBIO: UDI/DI 85412530642, g) PC0608SNBIO: UDI/DI 85412530673, h) PC0814SNBIO: UDI/DI 85412530697, All serial numbers |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0668-2024%22
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