FDA Device Recall Z-0511-2024

Nurse Assist, LLC · Haltom City, TX

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

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

Lot / serial / GTIN: Product Code/UDI-DI/Lot: 9210/20850020865042/21122520, 21122573, 22032938; 1203-BP/B1501203BP4/22022797; 1205-BP/B1501205BP4/22022789, 23024788; 1210-BP/B1501210BP4/21112359, 21112384, 21112388, 21112441, 21112451, 21122519, 21122550, 21122588, 21122614, 22012632, 22012669, 22012668, 22012672, 22012673, 22012677, 22012689, 21122572, 22012678, 22022824, 22012690, 22022827, 22022853, 22022857, 22032891, 22032923, 22032922, 22032935, 22032936, 22032937, 22032962, 22033016, 22032963, 22033026, 22033038, 22033061, 22033083, 22043095, 22043129, 22043135, 22043154, 22043172, 22043186, 22043210, 22043214, 22043227, 22043240, 22043253, 22053259, 22053270, 22053260, 22053282, 22053281, 22053293, 22053306, 22053333, 22053326, 22053341, 22053364, 22053382, 22063384, 22063411, 22063428, 22063416, 22063459, 22063481, 22063510, 22063523, 22063538, 22063554, 22073576, 22073596, 22073626, 22073668, 22073712, 22083756, 22083766, 22083798, 22083830, 22083894, 22083899, 22083917, 22093934, 22093951, 22093983, 22094015, 22094027, 22094057, 22094058, 22094076, 22094097, 22094121, 22104141, 22104149, 22104168, 22104182, 22104200, 22104226, 22104246, 22104278, 22114301, 22114328, 22114349, 22114366, 22114390, 22114413, 22114433, 22124485, 22124510, 22124529, 23014706, 23014528, 23014755, 23024867, 23045258, 23055569, 23065893, 23065922, 23086215, 23086351, 23096407; PFF001/20810062438895/23014656, 23014671; SS003/20885632389778/23035163, 23055622, 23086334; SS005/20885632389761/23035151, 23055649, 23076007, 23086323; SS010/20885632389754/23024926, 23035099, 23035143, 23045223, 23045305, 23055455, 23055658, 23065737, 23065794, 23065853, 23065958, 23065967, 23075984, 23076039, 23076086, 23076105, 23076121, 23086157, 23086189, 23086248, 23086264; SS010SFR/not distributed.

Quantity: 61,740 Cases

Reason for recall

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.

Recall record

Recall number: Z-0511-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
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
Recall initiated: 2023-11-06
Classified by FDA Center: 2023-12-20
FDA published: 2023-12-27
Recalling firm: Nurse Assist, LLC
Firm location: Haltom City, TX

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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