Baxter Healthcare Corporation has issued a recall for approximately 26,635 units of Peri-Guard and Supple Peri-Guard Repair Patches because they should no longer be used in neurosurgery procedures. A new warning (contraindication) has been added to the instructions because the endotoxin levels in these patches may be higher than what is allowed for devices that come into contact with cerebrospinal fluid. This recall affects various product codes and all lots that are currently within their expiration dates. If you have had a procedure involving these patches, or if you are a healthcare provider using these products, please contact your doctor or the manufacturer for guidance.
The use of these patches in neurosurgery could expose patients to endotoxin levels that exceed safety limits for devices contacting cerebrospinal fluid. High endotoxin levels in the central nervous system can cause serious inflammatory reactions or other adverse health complications.
Addition of a new contraindication to the Instructions for Use (IFU).
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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