FDA-Device2024-08-28Class II

Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b) BRONCH KIT, REF DYKE1007B; c) ENT, REF DYNJ909935; d) NASAL SINUS-LF, REF DYNJ902624G; e) ORAL, REF DYNJ902377I; f) PACK,BRONCHOSCOPY, REF DYNJ65475B; g) PACK,HEAD AND NECK, REF DYNJ65487B; h) PACK,SINUS, REF DYNJ906898; i) PACK,T & A, REF DYNJ906897B; j) PACK,T & A ASC, REF DYNJ906914; k) T AND A, REF DYNJ909941

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
6998 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b) BRONCH KIT, REF DYKE1007B; c) ENT, REF DYNJ909935; d) NASAL SINUS-LF, REF DYNJ902624G; e) ORAL, REF DYNJ902377I; f) PACK,BRONCHOSCOPY, REF DYNJ65475B; g) PACK,HEAD AND NECK, REF DYNJ65487B; h) PACK,SINUS, REF DYNJ906898; i) PACK,T & A, REF DYNJ906897B; j) PACK,T & A ASC, REF DYNJ906914; k) T AND A, REF DYNJ909941

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2703-2024

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