Sklar Instruments ECONO STERILE surgical procedure kits recalled due to packaging defect
Sklar Instruments is recalling ECONO STERILE ALFONSO INFANT SPEC STRL sterile surgical procedure kits nationwide due to packaging issues that may breach the sterile barrier.
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: This is a risk-of-harm medical device where sterility integrity is critical to safe use. No illnesses or injuries have been reported, and the hazard remains theoretical. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Sklar Instruments is recalling ECONO STERILE ALFONSO INFANT SPEC STRL sterile surgical procedure kits designed for eyelid surgery. These are single-use, pre-sterilized surgical instrument kits.
The recall was initiated due to reports of various packaging issues that may result in a breach of the sterile barrier.
The affected kits have model number 96-3814 and were distributed nationwide to healthcare facilities. Surgical centers and hospitals with these kits should immediately cease use and contact Sklar Instruments regarding product return or replacement. Patients who have undergone eyelid surgery using these kits and have concerns should consult their surgeon.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814; eyelid surgery
- Manufacturer
- Sklar Instruments
- Hazard
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 (3)
- 96-3814
- UDI/DI 50649111455986
- Lot codes: 050824-01¿¿ ¿
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 recalled by Sklar Instruments under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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