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
This recall is currently active, issued August 8, 2025. It was issued by Carefree Surgical Specialties.
- Company
- Carefree Surgical Specialties
- Recall Initiated
- July 1, 2025
- Posted
- August 8, 2025
- Recall Number
- Z-2283-2025
- Quantity
- 500
- Firm Location
- Nampa, ID
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
Lot Code: Lot Number: 1650 UDI Code: Not Available
Root Cause
Process control
Action Taken
On 07/9/2025 and 07/14/2025, the firm send via email and certified mail an "URGENT: MEDICAL DEVICE VOLUNTARY RECALL" Letter to customers informing them of two product issues: 1. the potential presence of foreign matter contamination within some units. 2. packaging discrepancy involving the number of gauze packs contained within sealed units. Customers are instructed to: For Issue 1: 1. Discontinue Use: Discontinue use of any unopened packages of SKU 15506/25 from Lots 1607. 2.Report any findings: Report any findings to Carefree Surgical using the contact information below. 3.Return or Dispose of Affected Product: "Customers may return affected product to Carefree Surgical Specialties, Inc. A shipping label will be provided upon request. "Or, if preferred, Customers may dispose of affected units per your facility s procedures and notify us for documentation and replacement coordination. 4.Do not use, resell, or further distribute affected product. For Issue 2: 1.Inspect their inventory: Visually check all unopened packages of SKU 15508/25 from Lots 1595 and SKU 15505/25 from Lots 1645 and 1650 to confirm each contains five (5) sterile gauze rolls 2.Report any discrepancies: If any units contain more than 5 rolls, please notify us immediately using the contact information below. 3.Return or Dispose of Affected Product: "Customers may return affected product to Carefree Surgical Specialties, Inc. A shipping label will be provided upon request. "Or, if preferred, Customers may dispose of affected units per your facility s procedures and notify us for documentation and replacement coordination. 4.Do not use, resell, or further distribute affected product. Any questions or need assistance with returns or replacements, please contact: Attn: Sarah Monroe Carefree Surgical Specialties, Inc. (916)663-4082 or support@carefreesurgical.com