Kittner gauze rolls had biological foreign matter and wrong pack quantity
Carefree Surgical Specialties Robotic/Laparoscopy Kittner Rolls Gauze is being recalled for product contamination with biological foreign matter that could compromise sterility, and an incorrect quantity of gauze 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: Risk-of-harm product: biological foreign matter that could compromise sterility on gauze used inside the surgical field, with no infection reported.
Plain-English summary
Carefree Surgical Specialties Robotic/Laparoscopy Kittner Rolls Gauze, medium, 4 inches long, x-ray detectable, 5 per pack, 25 packs per case, catalog number 15505/25, is being recalled. The action covers 500 units from lot 1650.
The stated reason covers two issues: product contamination with biological foreign matter that could compromise sterility, and an incorrect quantity of gauze in the sterile packaging. The FDA classified the action as Class II. The source does not report any infection having occurred.
Distribution was nationwide in the United States, including Kentucky, Texas, Florida, North Carolina, Colorado, California, Idaho, West Virginia and New York. The gauze is supplied to surgical facilities rather than sold to consumers.
Facilities should identify affected stock using the catalog number and lot number above, quarantine it, and follow the instructions issued by the manufacturer.
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
- Category
- Medical Device — Surgical gauze
- Hazard
- biological-foreign-matter
- sterility-compromise
- incorrect-quantity
- class-ii
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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