FDAFDA · Food and drugs·Recall number Z-1379-2024
Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225
Published April 3, 2024 · Recall initiated: February 28, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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