—#206464

Product

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

FDA product code: FTM — Mesh, Surgical
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K983162
Affected lot / code info: a) PC0404NBIO, UDI/DI 00085412530529; b) PC0608NBIO, UDI/DI 00085412530567; c) PC0814NBIO, UDI/DI 00085412530581; d) PC1016NBIO, UDI/DI 00085412530604; ALL LOTS WITHIN EXPIRY

Why it was recalled

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 (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

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.

Timeline

Recall initiated: 2024-02-28
Posted by FDA: 2024-03-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206464. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.