Device 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
Z-0668-2024
Product summary
- Event
- Event 93503
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-0668-2024
Official wording
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).
Code information: 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
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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).