Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIO

Reason: 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.

Code information: a) PC0404NBIO, UDI/DI 00085412530529; b) PC0608NBIO, UDI/DI 00085412530567; c) PC0814NBIO, UDI/DI 00085412530581; d) PC1016NBIO, UDI/DI 00085412530604; 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.