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fda_recall · device_recall · high

Baxter Healthcare Corporation — Class II recall: Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC…

Event date
2024-04-03 00:00:00Z
Observed
2026-07-16 23:20:10Z
Source ID
Z-1377-2024
Payload hash
21c99771d0871dc6a0a454cd

Summary

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 ne… Status: Ongoing.

Frequently asked questions

Has Baxter Healthcare Corporation had other FDA enforcement actions?
Yes. Argus HQ has recorded 208 total FDA actions tied to Baxter Healthcare Corporation: 0 warning letters, 208 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2024-04-03; Argus observed and indexed it on 2026-07-16.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA
Argus HQ Research (2024). Baxter Healthcare Corporation — Class II recall: Baxter Peri-Guard Repair Patch (legacy product codes):    a) PC0404NBIO,   b) PC…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-1377-2024
MLA
"Baxter Healthcare Corporation — Class II recall: Baxter Peri-Guard Repair Patch (legacy product codes):    a) PC0404NBIO,   b) PC…." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-1377-2024.
Chicago
Argus HQ Research. "Baxter Healthcare Corporation — Class II recall: Baxter Peri-Guard Repair Patch (legacy product codes):    a) PC0404NBIO,   b) PC…." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-1377-2024.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_baxter_healthcare_corporation_z_1377_2024_2024,
  title = {Baxter Healthcare Corporation — Class II recall: Baxter Peri-Guard Repair Patch (legacy product codes):    a) PC0404NBIO,   b) PC…},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-baxter-healthcare-corporation-z-1377-2024},
  note = {Accessed: July 17, 2026}
}

Informational only. Not legal, financial, or medical advice.