Reported Jan 22, 2025 · Ongoing
ECONO STERILE medical procedure kits labeled as
Sklar Instruments
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: Sklar Instruments · 1333 Lenape Rd · West Chester, PA · 19382-6816
Is this the product you have?
ECONO STERILE medical procedure kits labeled as
12 of 12 products
| Model / number | Product as published |
|---|---|
96-4176 | ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10 |
96-4177 | ECONO STERILE YANKAUER SUCTION TUBE 11" CS10 |
96-5434 | ECONO STERILE FRAZIER TUBE 6FR STERILE CS/25 |
96-5435 | ECONO STERILE FRAZIER TUBE 7FR STERILE CS/25 |
96-5436 | ECONO STERILE FRAZIER TUBE 8FR STERILE CS/25 |
96-5437 | ECONO STERILE FRAZIER TUBE 9FR STERILE CS/25 |
96-5438 | ECONO STERILE FRAZIER TUBE 10FR STERILE CS25 |
96-5439 | ECONO STERILE FRAZIER TUBE 12FR STERILE CS25 |
96-5440 | ECONO STERILE FRAZIER TUBE 14FR STERILE CS25 |
96-5492 | ECONO STERILE BARON SUCT TUBE 3FR STER CS25 |
96-5493 | ECONO STERILE BARON SUCT TUBE 5FR STER CS25 |
96-5494 | ECONO STERILE BARON SUCT TUBE 7FR STER CS25, ; suction devices |
- Lot codes and dates
12 of 12 products
Products covered by this recall # Barcodes Product as published 1 5064911149367496-4176, UDI/DI 50649111493674, Lot codes: FSS4, FSS5 2 5064911149368196-4177, UDI/DI 50649111493681, Lot codes: FSS4, FSS5 3 5064911149361296-5434, UDI/DI 50649111493612, Lot codes: FSS4, FSS5 4 5064911149362996-5435, UDI/DI 50649111493629, Lot codes: FSS4, FSS5, FSS6 5 5064911149363696-5436, UDI/DI 50649111493636, Lot codes: FSS4, FSS5 6 5064911149364396-5437, UDI/DI 50649111493643, Lot codes: FSS4, FSS5 7 5064911149365096-5438, UDI/DI 50649111493650, Lot codes: FSS4, FSS5 8 5064911149366796-5439, UDI/DI 50649111493667, Lot codes: FSS4, FSS5 9 5064911149396496-5440, UDI/DI 50649111493964, Lot codes: FSS4, FSS5 10 5064911148165796-5492, UDI/DI 50649111481657, Lot codes: FSS4, FSS5 11 5064911148166496-5493, UDI/DI 50649111481664, Lot codes: FSS4, FSS5 12 5064911148167196-5494, UDI/DI 50649111481671, Lot codes: FSS4, FSS5. - Amount recalled
- 150 units
This recall covers 30 products
The agency filed one notice per product. You are reading one of them; the other 29 are below.
17 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Reports of various packaging issues that may result in a breach of the sterile barrier.
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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