Baxter Healthcare Corporation: Medical Device Recall in 2024 - (Recall #: Z-1379-2024)

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:

Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225

Product Classification:

Class II

Date Initiated: February 28, 2024

Date Posted: April 3, 2024

Recall Number: Z-1379-2024

Event ID: 94152

Reason for Recall:

A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices.

Status: Ongoing

Product Quantity: 2413 units

Code Information:

a) PG0404, UDI/DI 00085412818405; b) PG0608, UDI/DI 00085412818443; c) PG0814, UDI/DI 00085412818597; d) PG1016, UDI/DI 00085412818610; e) PG1225, UDI/DI 00085412818658; ALL LOTS WITHIN EXPIRY

Distribution Pattern:

US Distribution to states of: CT, VA, TX, PA and IL; and OUS (foreign) countries of: Austria, Finland, Germany, Greece, Ireland, Italy, Poland, Spain, Sweden, Switzerland, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated