Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016

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) SPG0404, UDI/DI 00085412818672; b) SPG0406, UDI/DI 00085412818696; c) SPG0608, UDI/DI 00085412818313; d) SPG0814, UDI/DI 00085412818375; e) SPG1016, UDI/DI 00085412818429; 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.