FDA-Device2023-02-22Class II
Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number DYNDA2524 b) CENTURION MEDICAL PRODUCTS DIALYSIS ON/OFF BUNDLE, Reorder Number DT22705A c) CENTURION MEDICAL PRODUCTS ULTRASOUND PIV BUNDLE, Reorder Number IV8635D d) CENTURION MEDICAL PRODUCTS CUTDOWN TRAY, Reorder Number MNS12595
MEDLINE INDUSTRIES, LP - Northfield
Hazard
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
Sold states
Nationwide
Affected count
630 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number DYNDA2524 b) CENTURION MEDICAL PRODUCTS DIALYSIS ON/OFF BUNDLE, Reorder Number DT22705A c) CENTURION MEDICAL PRODUCTS ULTRASOUND PIV BUNDLE, Reorder Number IV8635D d) CENTURION MEDICAL PRODUCTS CUTDOWN TRAY, Reorder Number MNS12595
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1118-2023Don't want to check this manually?
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