Z-2283-2025 Class II Ongoing
FDA device recall Z-2283-2025 was initiated by Carefree Surgical Specialties on July 1, 2025 and is designated Class II. Reason for recall: Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging The recall status is ongoing. Affected quantity: 500.
Recall Details
- Product Type
- Devices
- Report Date
- August 20, 2025
- Initiation Date
- July 1, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 500
Product Description
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/CS
Reason for Recall
Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging
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.
Code Information
Lot Code: Lot Number: 1650 UDI Code: Not Available