Reported Jan 17, 2024 · Ongoing
PERI-GUARD SUPPLE, Product Codes
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?
PERI-GUARD SUPPLE, Product Codes
8 of 8 products
| Model / number | Product as published |
|---|---|
SPG1016 | PERI-GUARD SUPPLE, Product Codes: a) |
SPG0404 | 10X16 CM US, TS; b) |
SPG0608 | 4 X 4 CM US, TS; c) |
SPG0814 | 6 X 8 CM US, TS; d) |
PC1016SNBIO | 8 X 14 CM US, TS; e) |
PC0404SNBIO | 10X16 CM US; f) |
PC0608SNBIO | 4X4 CM US; g) |
PC0814SNBIO | 6X8 CM US; h) |
- Lot codes and dates
- a) SPG1016UDI/DI 85412818429
- b) SPG0404UDI/DI 85412818672
- c) SPG0608UDI/DI 85412818313
- d) SPG0814UDI/DI 85412818375
- e) PC1016SNBIOUDI/DI 85412530710
- f) PC0404SNBIOUDI/DI 85412530642
- g) PC0608SNBIOUDI/DI 85412530673
- h) PC0814SNBIOUDI/DI 85412530697, All serial numbers
This recall covers 17 products
The agency filed one notice per product. You are reading one of them; the other 16 are below.
4 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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).
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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