Recall Z-0668-2024 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Baxter Healthcare Corporation
PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8 CM US, TS; d) SPG0814: 8 X 14 CM US, TS; e) PC1016SNBIO: 10X16 CM US; f) PC0404SNBIO: 4X4 CM US; g) PC0608SNBIO: 6X8 CM US; h) PC0814SNBIO: 8X14 CM US
| Date | Jan 5, 2024 (initiated Dec 6, 2023) |
| Status | Open, Classified |
| 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). |
| Root cause | Under Investigation by firm |
| Action | Baxter issued an IMPORTANT PRODUCT INFORMATION to its consignees on 12/06/2023 via USPS first class mail. The notice explained the issue, potential hazard involved, and requested the following: Actions to be Taken by Customers: 1. Healthcare providers may continue to safely use the products listed above while following the associated Instructions for Use. 2. Cease any further distribution of the Cardiovascular Surgery marketing brochure for the products listed above. All copies of this marketing brochure should be promptly discarded. The brochure reference number, US-AS46-220001, can be fou |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223052 | Peri-Guard and Supple Peri-Guard Synovis Life Technologies, Inc., Apr 7, 2023 |