Device 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 Detectable 5pk 25pk/CS Roll Gauzes
Z-2284-2025
Product summary
- Event
- Event 97259
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 65
- Official record key
device-enforcement:Z-2284-2025
Official wording
Reason: Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
Code information: Lot Code: Lot Number: 1607 UDI Code: Not Available
Distribution pattern: US Nationwide distribution in the states of KY, TX, FL, NC, CO, CA, ID, WV, NY, IL, IN, IA, MI, LA, WI, MT, VA, MA, TN, CT, AL, PA, MO, NJ, AR, OH, NE, AZ, MN, MD, GA, NC, WA, VT, OK, RI, SC, NH, VT, NV, OR.
Derived failure modes
-
Foreign material or chemical contamination
foreign matter