Baxter Healthcare Corporation: Medical Device Recall in 2024 - (Recall #: Z-0668-2024)

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 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

Product Classification:

Class II

Date Initiated: December 6, 2023

Date Posted: January 17, 2024

Recall Number: Z-0668-2024

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) 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.

Voluntary or Mandated:

Voluntary: Firm initiated