Recall Z-2230-2024— MEDLINE INDUSTRIES, LP - Northfield

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-03-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch with component Reorder #DYNJ040408, Kelly Forceps/STD STR Sterile. b. Medline Adult/Child Intubation Kit, Pack #ACC010616 and Pack #ACC010616H, containing a Pure Pouch with component Reorder #66790, Sterile Magill Forceps. c. Medline Intubation Tray (Adult), Pack #DYNJAA245A, containing a Pure Pouch with component Reorder #66790, Sterile Magill Forceps. d. Medline Adult Main Disp. Intub Part A, Pack #DYNJAA262A, containing a Pure Pouch with component Reorder #66790, Sterile Magill Forceps. e. Medline Adult Anesthesia Tray, Pack #DYNJAA276, containing a Pure Pouch with component Reorder #66790, Sterile Magill Forceps. f. Medline Baby Care Kit, Pack #DYKL1025 and Pack #DYKL1025H, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile.. Reason: Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails..

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Classification

Class II

Status

Ongoing

Initiated

2024-03-14

Firm location

Northfield, IL, United States

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