FDA Enforcement Class II Ongoing

See RES Description

Recall: Z-2625-2024 · Reported September 4, 2024

Enforcement

Recall Number: Z-2625-2024
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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PAIN0157G, Lot Number 21DLA080 ; PAIN0157G, Lot Number 21FLA196 ; PAIN0157G, Lot Number 21HLA562 ; PAIN0157G, Lot Number 21JLA095 ; PAIN

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Distribution

Worldwide distribution.

Quantity

1,679,067 units in total