RegWardenFDA facility compliance records
Facility

NURSE ASSIST, LLC

2 recall(s) on record — most severe on record: Class I.

Activity by year

FDA actions on record by year2016: 1 recalls, 1 inspections; 2017: 1 warning letters; 2018: 1 inspections; 2020: 1 inspections; 2023: 1 recalls, 1 inspections2201612017120182019120202021202222023202420252026
  • Recalls (2)
  • Inspections (4)
  • Warning letters (1)

Devices registered here (1)

  • Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
    Product code FCM (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5130

Recalls & enforcement

  • Class IOngoing2023-11-06
    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.
  • Class ITerminated2016-10-04
    Potential contamination with B. cepacia.

FDA inspections (4)

  • OAI2023-09-21
    Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • NAI2020-03-09
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • NAI2018-10-25
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • OAI2016-11-23
    Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “NURSE ASSIST, LLC (FEI 3002695476) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002695476-nurse-assist-llc/

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