Carefree Kittner Rolls Surgical Gauze Recalled for Contamination and Incorrect Quantity
Carefree Surgical Specialties is recalling Robotic/Laparoscopy Kittner Rolls Gauze due to biological contamination that could compromise sterility and incorrect quantities in sterile packaging.
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: The product contains biological contamination that could compromise sterility in a surgical application. No injuries or illnesses have been reported. As a risk-of-harm product without reported injury, this receives a High severity score per the FDA classification rubric.
Plain-English summary
Carefree Surgical Specialties is recalling Robotic/Laparoscopy Kittner Rolls Gauze (Model 15505/25, Lot 1650) distributed nationwide across multiple states.
The product is subject to recall for two reasons: biological foreign matter contamination that could compromise sterility, and incorrect quantities of gauze in sterile packages. These defects affect the product's safety and quality for surgical use.
This recall affects healthcare facilities and surgical centers that received the affected product. Sterility is critical for surgical gauze, and the contamination in this product could pose risks in surgical applications.
The recalled product
- Product
- Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/CS Model/Catalog Number: 15505/25 Product Description: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long X-Ray Detectable 5/pk 25pk/
- Manufacturer
- Carefree Surgical Specialties
- Hazard
- biological-contamination
- sterility-compromise
- incorrect-quantity
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 (1)
- Lot Code: Lot Number: 1650 UDI Code: Not Available
Distribution
Distributed nationwide across the United States.
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