Recall Z-1378-2024 ยท FTM Mesh, Surgical
Baxter Healthcare Corporation
Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO
| Date | Mar 26, 2024 (initiated Feb 28, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Labeling Change Control |
| Action | 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. |
| Quantity | 9549 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983162 | PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC Bio-Vascular, Inc., Oct 9, 1998 |