Recall Z-2284-2025 ยท GDY Gauze/Sponge, Internal, X-Ray Detectable
Carefree Surgical Specialties
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
| Date | Aug 8, 2025 (initiated Jul 1, 2025) |
| Status | Open, Classified |
| Reason | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging |
| Root cause | Process control |
| Action | 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 |
| Quantity | 65 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K882708 | GAUZE SPONGE, X-RAY DETECTABLE Bioseal, Aug 3, 1988 |