FDA recall Z-1646-2023

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B.

Reason for recall

The kits were damaged by water.

Distribution

Distribution was made to California. There was no foreign/government/military distribution.

Key facts

Status
Ongoing
Initiation date
2023-04-21
Report date
2023-06-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1646-2023