See RES description

Enforcement

• Recall Number: Z-2626-2024
• Event ID: 94582
• Classification: Class II
• Status: Ongoing
• Product Type: Devices
• Firm: MEDLINE INDUSTRIES, LP - Northfield
• Voluntary / Mandated: Voluntary: Firm initiated
• Initial Notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
• Report Date: September 4, 2024
• Initiation Date: April 8, 2024
• Classification Date: August 28, 2024
• Address: 3 Lakes Dr, Northfield, IL, 60093-2753, United States

Description

See RES description

Reason

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Code Info

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SPEC0234 , Lot Number 20FBK197 ; SPEC0234 , Lot Number 23JBS217 ; SPEC0234 , Lot Number 20HBC676 ; SPEC0234 , Lot Number 20WBA680 ; SPEC0234 , Lot Number 20LBT994 ; SPEC0234 , Lot Number 21EBS849

Distribution

Worldwide distribution.

Quantity

1,679,067 units in total

Recall Classification

• Class II

Moderate — may cause temporary or medically reversible health consequences.

Firm

MEDLINE INDUSTRIES, LP - Northfield

Northfield, IL, United States