Home / Recalls / Baxter Healthcare Corporation / Z-0665-2024

Z-0665-2024 Class II Ongoing

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
January 17, 2024
Initiation Date
December 6, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

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

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 Pattern

US Nationwide distribution.

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

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