Product Safety Recalls

Product Recall Tracker

Baxter Healthcare Corporation Recall 94152

Description: Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO

Baxter Healthcare Corporation Recall 94152 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1378-2024
Event ID94152
Event DescriptionBaxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO
Product TypeDevices
DistributionUS 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.
Quantity9549 units
Recall ReasonA 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.
Device Classification20240403
Device Code Infoa) PC0404SNBIO, UDI/DI 00085412530642; b) PC0608SNBIO, UDI/DI 00085412530673; c) PC0814SNBIO, UDI/DI 00085412530697; d) PC1016SNBIO, UDI/DI 00085412530710; ALL LOTS WITHIN EXPIRY
Center Classification Date20240326
Recall Initiation Date20240228
Recalling FirmBaxter Healthcare Corporation
Initial Notification Letter
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.