Recall Z-0514-2024 ยท FRO Dressing, Wound, Drug
Nurse Assist, LLC
Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER FOIL LID 120 ML/T167005; CUP STERILE SALINE FOIL LID 120 ML/T167007
| Date | Dec 20, 2023 (initiated Nov 6, 2023) |
| Status | Open, Classified |
| Reason | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection. |
| Root cause | Process control |
| Action | On 11/6/23, the firm issued a press release. On 11/09/23, "URGENT: MEDICAL DEVICE RECALL" notices and response forms were emailed and mailed to direct customers and distributors, who were provided with a separate customer recall notice they could forward to their customers. Customers were asked to do the following: 1) Quarantine and then return affected devices. 2) If affected products were further distributed, send these customers the attached recall notice that asks customers to return affected devices to their distributors. 3) Distributors are asked to follow up with customers to ensure |
| Quantity | 432 Cases |
| Distribution | US Nationwide Distribution: SC AZ, CA, FL, GA, HI, IA, IN, KS, KY, MA, ME, MN, MS, NC, ND, NE, NJ, NV, NY, OH, PA, RI, TX, WA, WI, AK, AL, AR, CO, CT, DC, ID, IL, LA, MD, MI, MO, MT, NH, NM, OK, OR, PR, SD, TN, UT, VA , WI, WV, WY. OUS (foreign) distribution to: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.