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

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) 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.