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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Nurse Assist, LLC
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full 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

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0511-2024

Related Recalls

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.

Nov 6, 2023 Surgical Instruments Nationwide View Details β†’

Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML STERILE SALINE BOTTLE/1020, 100ML STERILE SALINE BOTTLE/1022, 100ML STERILE WATER BOTTLE/1024, 100ML STERILE WATER BOTTLE/10000, 100ML STERILE WATER BOTTLE/PT00103419, 100ML STERILE SALINE BOTTLE/PT00103427; COVIDIEN: STERILE WOUND SOLUTION/90SAL, STERILE WOUND SOLUTION/210SAL; HAYLARD OWENS MINOR: 250ML STERILE WATER BOTTLE/49148, 250ML STERILE SALINE BOTTLE/49152, 1000ML STERILE SALINE BOTTLE/49154, 100ML STERILE SALINE BOTTLE/49155, 1000ML STERILE WATER BOTTLE/49150, 100ML STERILE WATER BOTTLE/49151, 500ML STERILE WATER BOTTLE/49149, 500ML STERILE SALINE BOTTLE/49153; IDEXX: BOTTLE STERILE WATER 10 PACK/98-09444-01; MCKESSON: 100ML STERILE SALINE BOTTLE/37-6240, 500ML STERILE WATER BOTTLE/37-6290, 250ML STERILE SALINE BOTTLE/37-6270, 500ML STERILE SALINE BOTTLE/37-6280, 120ML STERILE WATER CUP/37-6210, 1000ML STERILE SALINE BOTTLE/37-6281, 1000ML STERILE WATER BOTTLE/37-6291, 120ML STERILE SALINE CUP/37-6220, 100ML STERILE WATER BOTTLE/37-6250, 250ML STERILE WATER BOTTLE/37-6260, 210ML SALINE WOUND FLUSH/37-6507, 88.7ML SALINE WOUND FLUSH STERILE/37-6503; MEDICHOICE OWENS MINOR: CAN STERILE SALINE SPRY MEDI 7.1 OZ/SWF071; MEDLINE: 110ML STERILE SALINE CUP/DYND40540, 100ML STERILE SALINE BOTTLE/RDI30296, 250ML STERILE WATER BOTTLE/PCS1550, 250ML STERILE SALINE BOTTLE/PCS1650, 1000ML STERILE SALINE BOTTLE/DYND1000MLS, 100ML STERILE SALINE BOTTLE/52011, 500ML STERILE WATER BOTTLE/DYND500MLW, 500ML STERILE SALINE BOTTLE/DYND500MLS, 100ML STERILE WATER BOTTLE/RDI30295, CAN SALINE STERILE SPRAY CURAD/CURSALINE7, 110ML STERILE WATER CUP/DYND40570, 100ML STERILE WATER BOTTLE/54380; NURSE ASSIST: 100ML STERILE SALINE BOTTLE/6492775, 100ML STERILE WATER BOTTLE/6492776; STERICARE: 90ML USP SALINE WOULD FLUSH/6503, 100ML STERILE SALINE BOTTLE/6240, 100ML STERILE WATER BOTTLE/6250, 250ML STERILE SALINE BOTTLE/6270, 500ML STERILE WATER BOTTLE/6290, 250ML STERILE WATER BOTTLE/6260, 500ML STERILE SALINE BOTTLE/6280, 1000ML STERILE SALINE BOTTLE/6281, 1000ML STERILE WATER BOTTLE/6291, 210ML SALINE WOUND FLUSH/6507, 120ML STERILE SALINE FOIL LID CUP/6220, 120ML STERILE WATER FIOL LID CUP/6210, 500ML STERILE WATER BOTTLE/5290, 500ML STERILE SALINE BOTTLE/5280; VYAIRE: CUP STERILE SALINE FOIL LID 120 ML/4873C

Nurse Assist

Class I - Dangerous

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.

Nov 6, 2023 Other Medical Devices Nationwide View Details β†’