FDA Enforcement
Class II
Ongoing
Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO: 12X25CMUS, c) PC0404NBIO: 4X4CMUS, d) PC0608NBIO: 6X8CMUS, e) PC0814NBIO: 8X14CMUS
Recall: Z-0665-2024
·
Reported January 17, 2024
Enforcement
- Recall Number
- Z-0665-2024
- Event ID
- 93503
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Baxter Healthcare Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 17, 2024
- Initiation Date
- December 6, 2023
- Classification Date
- January 5, 2024
- Address
- 1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States
Description
Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO: 12X25CMUS, c) PC0404NBIO: 4X4CMUS, d) PC0608NBIO: 6X8CMUS, e) PC0814NBIO: 8X14CMUS
Reason
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
Code Info
a) PC1016NBIO: UDI/DI 85412530604, b) PC1225NBIO: UDI/DI 85412530628, c) PC0404NBIO: UDI/DI 85412530529, d) PC0608NBIO: UDI/DI 85412530567, e) PC0814NBIO: UDI/DI 85412530581 All serial numbers
Distribution
US Nationwide distribution.