ECONO STERILE Gynecologic Biopsy Kits Recalled for Sterile Packaging Issues
Sklar Instruments is recalling ECONO STERILE gynecologic biopsy procedure kits because of 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 an FDA Class II medical device recall for a risk-of-harm product (sterile barrier breach in gynecologic biopsy kits). The source text describes a theoretical hazard with no reported illnesses or injuries, which per the rubric caps the score at 3 (High).
Plain-English summary
Sklar Instruments is recalling ECONO STERILE medical procedure kits used for gynecologic biopsies due to reports of packaging issues that may result in a breach of the sterile barrier. The recalled kits include two models: ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10 (Model Number 96-4134M) and ECONO STERILE OVAL BIOPSY FCP 3X7MM STER10 (Model Number 96-4137M), with affected lot codes SK-114 and SK-116.
The packaging issues reported could compromise the sterile barrier integrity of the medical procedure kits. A compromised sterile barrier could allow contamination during gynecologic biopsy procedures.
These kits were distributed nationwide in the United States. The recall affects any healthcare facilities or practitioners who received these specific models and lot codes.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M; 2) ECONO STERILE OVAL BIOPSY FCP 3X7MM STER10, Model Number 96-4137M; gynecologic biopsy
- Manufacturer
- Sklar Instruments
- Hazard
- sterile-barrier-breach
- packaging-defect
- contamination-risk
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 (6)
- 1) 96-4134M
- UDI/DI 50649111492547
- Lot codes: SK-114
- 2) 96-4137M
- UDI/DI 50649111492530
- Lot codes: SK-116.
Distribution
Distributed nationwide across the United States.
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