Reported Sep 5, 2018 · Ongoing
FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip…
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?
- FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter***." The pouches inside the cartons are labeled in part, "Floseal SPECIAL APPLICATOR TIPS***Baxter***"."
- Lot codes and dates
- Product Code1502186
- Box Lot Numbers
HA170718HA170818and HA170917
- Pouch Lot NumbersGR338160 and GR338384
- Amount recalled
- 46,908 pouches
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Baxter r recalled this device due to the use of an incorrect plastic formulation in the manufacture of the blue luer component of the FLOSEAL malleable tips.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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