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FDA (Device enforcement)Recalled 2023-12-06class ii

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

Hazard

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).

Details from the source

Reason for recall: 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). Distribution: US Nationwide distribution. Lot/code info: 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

UPC codes

85412530604, 85412530628, 85412530529, 85412530567, 85412530581

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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