Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b)… Recall
Issued April 3, 2024 · Baxter Healthcare Corporation
In April 2024, Baxter Healthcare Corporation recalled the Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b)…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b)… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Baxter Healthcare Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Baxter Healthcare Corporation
- Category
- Health
- Recall date
- April 3, 2024
- Units affected
- Not reported
- Sold at
- US Distribution to states of: CT, VA, TX, PA and IL; and OUS (foreign) countries of: Austria, Finland, Germany, Greece, Ireland, Italy, Pola
- Recall number
- FDA-Z-1378-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Baxter Healthcare Corporation has 36 recalls in our database, including 5 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.