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
8 of 8 products
| # | Product as published |
|---|---|
| 1 | ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A |
| 2 | ECONO STERILE WEITLANER RETR BL 2X3 4.5"CS25, Model Numbers: 96-2203A |
| 3 | ECONO STERILE WEITLANER RETR BL 3X4 5.5"CS25, Model Numbers: 96-2207A |
| 4 | ECONO STERILE WEITLANER RETR SH 3X4 5.5"CS25, Model Numbers: 96-2208A |
| 5 | ECONO STERILE WEITLANER RETR 3X4 SH 8" CS/10, Model Numbers: 96-2209A |
| 6 | ECONO STERILE WEITLANER RETR 3X4 BL 8" CS/10 , Model Numbers: 96-2210A |
| 7 | ECONO STERILE HOLZHEIMER RETR 4PRG SH 4"CS25, Model Numbers: 96-2241A |
| 8 | ECONO STERILE HOLZHEIMER RETR 4PRG BL 4"CS25, Model Numbers: 96-2242A; surgical retractor |
- Lot codes and dates
8 of 8 products
Products covered by this recall # Barcodes Product as published 1 5064911149310096-2201A, UDI/DI 50649111493100, Lot Codes: SK-120 2 5064911149309496-2203A, UDI/DI 50649111493094, Lot Codes: SK-120 3 5064911149311796-2207A, UDI/DI 50649111493117, Lot Codes: SK-120 4 5064911149312496-2208A, UDI/DI 50649111493124, Lot Codes: SK-120 5 5064911149315596-2209A, UDI/DI 50649111493155, Lot Codes: SK-120 6 5064911149316296-2210A, UDI/DI 50649111493162, Lot Codes: SK-130 7 5064911149282096-2241A, UDI/DI 50649111492820, Lot Codes: SK-115 8 5064911149283796-2242A, UDI/DI 50649111492837, Lot Codes: SK-115 - Amount recalled
- 75 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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