Sklar Instruments Sterile Surgical Kits Recalled for Packaging Defects
Sklar Instruments is recalling 252,865 sterile surgical kits nationwide due to packaging defects that may compromise the sterile barrier, risking instrument contamination.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with no reported illnesses or injuries. Sterile barrier breach on surgical instruments creates a risk of contamination, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sklar Instruments is recalling 252,865 units of ECONO STERILE medical procedure kits distributed nationwide. The recall involves 54 different model numbers of surgical instruments including scissors in various types and sizes. The FDA Class II recall was issued due to packaging issues that may result in a breach of the sterile barrier.
A breach in sterile barrier packaging allows potential contamination of the surgical instruments, compromising their sterility. Sterile instruments are essential for preventing infection during surgical procedures.
The recalled products were distributed nationwide to medical facilities and surgery centers. Healthcare providers using these products should discontinue use and seek replacement kits with intact sterile packaging. Specific affected lot codes are identified with each model number.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918; 2) ECONO STERILE METZENBAUM SCIS STR 9"STER C25,Model Number 941-1556; 3) ECONO STERILE MAYO SCISS STRT STRL 9" CS/25,Model Number 941-1613; 4) ECONO ST
- Manufacturer
- Sklar Instruments
- Hazard
- sterile-barrier-breach
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) 941-0918
- UDI/DI 50649111344174
- Lot codes MSS8
- 2) 941-1556
- UDI/DI 50649111447752
- Lot codes FSS19
- FSS23
- 3) 941-1613
- UDI/DI 50649111447912
- Lot codes FSS17
- 4) 94-1346
- UDI/DI 50649111256613
- Lot codes FSS8
- 5) 94-1925
- UDI/DI 50649111345966
- Lot codes FSS10
- FSS17
- FSS20
- 6) 94-4091
- UDI/DI 50649111288454
Distribution
Distributed nationwide across the United States.
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