Reported Apr 3, 2024 · Ongoing
Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIO
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- Baxter Peri-Guard
- Repair Patch (legacy product codes)
a) PC0404NBIOb) PC0608NBIOc) PC0814NBIOd) PC1016NBIO
- Lot codes and dates
a) PC0404NBIOUDI/DI 00085412530529b) PC0608NBIOUDI/DI 00085412530567c) PC0814NBIOUDI/DI 00085412530581d) PC1016NBIOUDI/DI 00085412530604ALL LOTS WITHIN EXPIRY
- Amount recalled
- 9899 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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