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
54 of 54 products
| Model / number | Product as published |
|---|---|
94-0286 | ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25 |
94-0290 | ECONO STERILE DRESSING FCP 5.5" CS/25LG |
94-0291 | ECONO STERILE TISSUE FCP 1X2 5.5" STER CS25 |
941-0691 | ECONO STERILE FRCPS JANSEN BAYO STRL6.25 C25 |
941-1414 | ECONO STERILE IRIS FCP SERR 4.25 STER CS100 |
94-1924 | ECONO STERILE PEDIATRIC MAGILL CATH FCP CS25 |
94-5034 | ECONO STERILE STRL ALLIGATOR FCPS 3.5" 25/CS |
94-6146 | ECONO STERILE SERR DRESSING FCP 5 1/2" CS/50 |
94-6616 | ECONO STERILE KELLY RANKIN FCP CVD 6.25 CS25 |
96-2215A | ECONO STERILE JANSEN NSL FCP BY6.5 STRLCS/25 |
96-2289 | ECONO STERILE BALLENGR SPNG FCP SERR7"CS/25 |
96-2293 | ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25 |
96-2293A | ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25 |
96-2295A | ECONO STERILE RUSSIAN TISSUE FCP 6" STER25 |
96-2351 | ECONO STERILE TISSUE FCP 1X2 8" STRL CS/25 |
96-2386 | ECONO STERILE SCHROEDER BRAUN TEN FCP10CS/25 |
96-2406 | ECONO STERILE TUBE OCCL FCP SM STR 7"STER 50 |
96-2408 | ECONO STERILE TUBE OCC FCP SM STR 7" STER 25 |
96-2410 | ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 50 |
96-2412 | ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25 |
- Lot codes and dates
149 of 149 products
Products covered by this recall # Barcodes Product as published 1 5064911109440694-0286, UDI/DI 50649111094406, Lot codes: FSF21 2 5064911109504594-0290, UDI/DI 50649111095045, Lot codes: SK-115 3 5064911109514494-0291, UDI/DI 50649111095144, Lot codes: 824940291, 924940291 4 50649111307902941-0691, UDI/DI 50649111307902, Lot codes: MST8, MST9 5 50649111464872941-1414, UDI/DI 50649111464872, Lot codes: SK-122 6 5064911134577594-1924, UDI/DI 50649111345775, Lot codes: FSF16, FSF22 7 5064911104068794-5034, UDI/DI 50649111040687, Lot codes: SK-112, SK-135 8 5064911121553594-6146, UDI/DI 50649111215535, Lot codes: SK-135 9 5064911128745794-6616, UDI/DI 50649111287457, Lot codes: SK-132 10 5064911148756796-2215A, UDI/DI 50649111487567, Lot codes: HSI 11 5064911143998696-2289, UDI/DI 50649111439986, Lot codes: SK-116 12 5064911144001296-2293, UDI/DI 50649111440012, Lot codes: SK-115, SK-132 13 5064911148759896-2293A, UDI/DI 50649111487598, Lot codes: HSI 14 5064911149325496-2295A, UDI/DI 50649111493254, Lot codes: HST21 15 5064911144008196-2351, UDI/DI 50649111440081, Lot codes: FST21 16 5064911144024196-2386, UDI/DI 50649111440241, Lot codes: FSF18 17 5064911103519596-2406, UDI/DI 50649111035195, Lot codes: FSF18, FSF24, FSF25 18 5064911103535596-2408, UDI/DI 50649111035355, Lot codes: FSF5, FSF12, FSF18, FSF26 19 5064911103566996-2410, UDI/DI 50649111035669, Lot codes: FST9 20 5064911103586796-2412, UDI/DI 50649111035867, Lot codes: FST6, FST9, FST10, FST11, FST12, FST20 - Amount recalled
- 245015 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.
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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