Recall Z-2315-2023— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-2315-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-15

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2023-05-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL CATHETER INSERTION TRAY, Model Number: CVI680C; b. CVC INSERTION ACCESSORY KIT, Model Number: ECVC7880; c. CVL INSERTION TRAY, Model Number: DYNDC1786A; d. ULTASOUND GUIDED PIV INSERTION, Model Number: IVS3635B; e. USG PIV INSERTION KIT, Model Number: DYNDV2480A;. Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2023-05-15
Firm location: Northfield, IL, United States

Product description

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL CATHETER INSERTION TRAY, Model Number: CVI680C; b. CVC INSERTION ACCESSORY KIT, Model Number: ECVC7880; c. CVL INSERTION TRAY, Model Number: DYNDC1786A; d. ULTASOUND GUIDED PIV INSERTION, Model Number: IVS3635B; e. USG PIV INSERTION KIT, Model Number: DYNDV2480A;

Reason for recall

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

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