FDA recall Z-1452-2024

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Distribution

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

Key facts

Status
Ongoing
Initiation date
2024-02-23
Report date
2024-04-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1452-2024