Recall Z-0512-2024— Nurse Assist, LLC

Name: FDA recall Z-0512-2024
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: K201286. Product: 0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240. 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

K201286 — 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouchNurse Assist, LLC·cleared 2020-08-11

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

0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240

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.