FDA-Device2024-10-30Class II

Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF DYNJ37909A; b) SHUNT PACK, REF DYNJ40040C

MEDLINE INDUSTRIES, LP - Northfield
Hazard

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Affected count
51 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF DYNJ37909A; b) SHUNT PACK, REF DYNJ40040C

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0173-2025

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