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Recall Observatory FDA recall evidence

Device product

Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO: 12X25CMUS, c) PC0404NBIO: 4X4CMUS, d) PC0608NBIO: 6X8CMUS, e) PC0814NBIO: 8X14CMUS

Z-0665-2024

December 06, 2023

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 93503
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-0665-2024

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) PC1016NBIO: UDI/DI 85412530604, b) PC1225NBIO: UDI/DI 85412530628, c) PC0404NBIO: UDI/DI 85412530529, d) PC0608NBIO: UDI/DI 85412530567, e) PC0814NBIO: UDI/DI 85412530581 All serial numbers

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).