FDA-Device2023-06-07Class II

Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B.

MEDLINE INDUSTRIES, LP - Northfield
Hazard

The kits were damaged by water.

Sold states
Distribution was made to California. There was no foreign/government/military distribution.
Affected count
342 packs (114 packs/product)
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1646-2023

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