Recall Z-0930-2023 ยท GFA Blade, Saw, General & Plastic Surgery, Surgical
MEDLINE INDUSTRIES, LP - Northfield
Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10 CARBON STEEL, Item Number: CISION10CS; b. STERILE BLADE NO. 10 CARBON STEEL RIB, Item Number: CISION10CSR; c. STERILE BLADE NO. 11 CARBON STEEL, Item Number: CISION11CS; d. STERILE BLADE NO. 11 STAINLESS STEEL, Item Number: CISION11SS; e. STERILE BLADE NO. 11 CARBON STEEL RIB, It
| Date | Jan 11, 2023 (initiated Nov 18, 2022) |
| Status | Open, Classified |
| Reason | Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging. |
| Root cause | Under Investigation by firm |
| Action | Medline notified customers on about 11/18/2022, via letter. Customers were instructed to immediately check stock for the affected item number and the affected lot numbers, and to destroy all affected product. Customers were also instructed to notify customers if the product was further distributed and to complete a response form. On 02/06/2023, the recall was expanded to include additional item numbers and consignees were notified. |
| Quantity | 76,053 units |
| Distribution | US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MD, MI, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.