Recall record at a glance
| Official record | Z-0511-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Ongoing |
| Recalling firm | Nurse Assist, LLC |
| Report date | Dec 27, 2023 |
| Recall initiation date | Nov 6, 2023 |
| Quantity | 61,740 Cases |
| Location | Haltom City, TX, United States |
Official product 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
Why the product was recalled
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.
Distribution information
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
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Press Release.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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