Baxter Healthcare Corporation Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIO Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIO
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
a) PC0404NBIO, UDI/DI 00085412530529, b) PC0608NBIO, UDI/DI 00085412530567, c) PC0814NBIO, UDI/DI 00085412530581, d) PC1016NBIO, UDI/DI 00085412530604, ALL LOTS WITHIN EXPIRY
Products Sold
a) PC0404NBIO, UDI/DI 00085412530529; b) PC0608NBIO, UDI/DI 00085412530567; c) PC0814NBIO, UDI/DI 00085412530581; d) PC1016NBIO, UDI/DI 00085412530604; ALL LOTS WITHIN EXPIRY
Baxter Healthcare Corporation is recalling Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBI due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Baxter issued a "SAFETY ALERT" to its consignees on 02/28/2024 via USPS first class mail. the notice explained the problem, potential hazard involved with off-label use of the product and the actions to be taken. The firm requested that the notice be forwarded all affected facilities or departments with institutions. Distributors are directed to notify their customers. For questions, contact Baxter Healthcare Center for Service at 888-229-0001, between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CT, IL, PA, TX, VA
Page updated: Jan 10, 2026