FDA recall Z-2702-2024

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A

Reason for recall

A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.

Distribution

Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.

Key facts

Status
Ongoing
Initiation date
2024-03-22
Report date
2024-08-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2702-2024