FDA-Device2024-08-28Class II
Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A, d) PACEMAKER, REF DYNJ901681D, e) UPPER ENDO KIT, REF DYKE1922A, f) VASCULAR, REF DYNJ905515D, g) VASCUALR, REF DYNJ902387K, h) VASCULAR III, REF DYNJS2035C
MEDLINE INDUSTRIES, LP - Northfield
Hazard
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Sold states
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
Affected count
26096 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A, d) PACEMAKER, REF DYNJ901681D, e) UPPER ENDO KIT, REF DYKE1922A, f) VASCULAR, REF DYNJ905515D, g) VASCUALR, REF DYNJ902387K, h) VASCULAR III, REF DYNJS2035C
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2701-2024Don't want to check this manually?
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