Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILLED SYRINGE/6496723, USP STERILE WATER SYRINGE/1030, 10CC PREFILLED SYRINGES/51638, 30CC PREFILLED SYRINGES/52333, 10CC PREFILLED SYRINGES/1010

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Product Code/UDI-DI/Lot: 1030A/B1501030A4/2001155, 2003041, 2005126, 2008103, 2102502, 2102567, 2102580, 2102600, 1812001, 22032961, 22114363, 23014570; 6496722/B15064967224/21081990, 22012631, 22012674, 22012712, 22022735, 22012715, 22022790, 22022814, 22022825, 22022858, 22032880, 22032882, 22043126, 22043146, 22043168, 22053339, 22053358, 22053248, 23014630, 23034993, 23035018, 23035017, 23045235; 6496723/B15064967234/22032892, 22032931, 22043213, 22114309, 22114358, 23034943; 1030/B15010304/22032995, 23014586; 51638/B150516384/22033023, 23014632; 52333/B150523334/22033017; 1010/B15010104/22063386, 22063498, 22073735, 23014593
  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:

Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILLED SYRINGE/6496723, USP STERILE WATER SYRINGE/1030, 10CC PREFILLED SYRINGES/51638, 30CC PREFILLED SYRINGES/52333, 10CC PREFILLED SYRINGES/1010

Product Codes/Lot Numbers:

Product Code/UDI-DI/Lot: 1030A/B1501030A4/2001155, 2003041, 2005126, 2008103, 2102502, 2102567, 2102580, 2102600, 1812001, 22032961, 22114363, 23014570; 6496722/B15064967224/21081990, 22012631, 22012674, 22012712, 22022735, 22012715, 22022790, 22022814, 22022825, 22022858, 22032880, 22032882, 22043126, 22043146, 22043168, 22053339, 22053358, 22053248, 23014630, 23034993, 23035018, 23035017, 23045235; 6496723/B15064967234/22032892, 22032931, 22043213, 22114309, 22114358, 23034943; 1030/B15010304/22032995, 23014586; 51638/B150516384/22033023, 23014632; 52333/B150523334/22033017; 1010/B15010104/22063386, 22063498, 22073735, 23014593

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0515-2024

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.

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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.

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