0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-BP; SOL: 0.9% SODIUM CHLORIDE IV FLUSH SYRINGE/PFF001; HALYARD OWENS MINOR: 0.9% USP SODIUM CHLORIDE INJECTION/SS003, 0.9% USP SODIUM CHLORIDE INJECTION/SS005, 0.9% USP SODIUM CHLORIDE INJECTION/SS010, 10ML SYRINGE STERILE/SS010SFR
Recall
- Recall Number
- Z-0511-2024
- Event Number
- 93434
- Firm
- Nurse Assist, LLC
- FEI Number
- 3002695476
- Product Code
- NGT
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- November 6, 2023
- Posted
- December 20, 2023
- Address
- 4409 Haltom Rd, Haltom City, TX, 76117-1207
Description
0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-BP; SOL: 0.9% SODIUM CHLORIDE IV FLUSH SYRINGE/PFF001; HALYARD OWENS MINOR: 0.9% USP SODIUM CHLORIDE INJECTION/SS003, 0.9% USP SODIUM CHLORIDE INJECTION/SS005, 0.9% USP SODIUM CHLORIDE INJECTION/SS010, 10ML SYRINGE STERILE/SS010SFR
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.
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 they received the recall notification and are taking appropriate action. 4) Distributors are asked to provide their Customer Shipment Report that lists all devices shipped to customers. The report should include the Shipment Date, Customer Name and Address, Part Number, Lot Number, and Quantity. This information is important to determine removal effectiveness. 5) Complete and return the response form via email to [email protected] 6) If your company repacked these medical devices into convenience kits, please contact your local FDA recall coordinator to evaluate the need for a new recall. The firm is arranging for removal and replacement of the affected product. The recall notice sent by distributors to their customers also asks that the notice be forwarded to the applicable personnel in their organization or to any organization where the Affected Devices were transferred. Customers with questions can call 800-649-6800, between the hours of 8am and 4:30pm (CST), or email [email protected]
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
61,740 Cases