Baxter Healthcare Corporation: Medical Device Recall in 2024 - (Recall #: Z-0664-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) PG1225: 12 X 25 CMUS, TS c) PG0404: 4 X 4 CMUS, TS d) PG0608: 6 X 8CMUS, TS e) PG0814: 8 X 14 CMUS, TS

Product Classification:

Class II

Date Initiated: December 6, 2023

Date Posted: January 17, 2024

Recall Number: Z-0664-2024

Event ID: 93503

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).

Status: Ongoing

Product Quantity:

Code Information:

a) PG1016: UDI/DI 85412818610, b) PG1225: UDI/DI 85412818658, c) PG0404: UDI/DI 85412818405, d) PG0608: UDI/DI 85412818443, e) PG0814: UDI/DI 85412818597, All serial numbers

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated