FDA-Device2024-10-30Class II
Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B
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
194 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0171-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief