FDA-Device2024-12-04Class II
Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Sold states
US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.
Affected count
48 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0534-2025Don't want to check this manually?
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