Kittner roll gauze with tail recalled over contamination and incorrect pack quantity
Carefree Surgical Specialties Kittner Roll Gauze + Tail, catalog 15506/25 lot 1607, is recalled for biological foreign matter that could compromise sterility and for incorrect gauze counts. 65 units are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; compromised sterility on a surgical product is a potential harm and no injuries are reported.
Plain-English summary
Carefree Surgical Specialties Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium, 4 inches long and X-ray detectable, supplied 5 per pack and 25 packs per case, model and catalog number 15506/25, is being recalled. The affected product carries lot number 1607. The recall covers 65 units distributed in Kentucky, Texas, Florida, North Carolina, Colorado, California, Idaho, West Virginia, New York, Illinois, Indiana, Iowa, Michigan, Louisiana, Wisconsin, Montana and Virginia.
The recall was issued for 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.
Hospitals and surgical centres holding this lot should quarantine it and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15506/25 Product Description: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray
- Manufacturer
- Carefree Surgical Specialties
- Hazard
- sterility-compromise
- foreign-matter
- 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: 1607 UDI Code: Not Available
Distribution
Distributed nationwide across the United States.
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