Recall Z-0515-2024— Nurse Assist, LLC

Name: FDA recall Z-0515-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-06

Class I · Ongoing

Class I FDA medical device recall by Nurse Assist, LLC, initiated 2023-11-06. It names one FDA 510(k) clearance: K030813. Product: 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. Reason: 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..

Recalling firm: Nurse Assist, LLC
Classification: Class I
Status: Ongoing
Initiated: 2023-11-06
Firm location: Haltom City, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K030813 — PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 ANDPrimary Care Solutions, Inc.·cleared 2003-05-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.