Z-3014-2024 Class II Ongoing

Recalled by MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL

Recall Details

Product Type
Devices
Report Date
September 18, 2024
Initiation Date
April 8, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Medline Convenience kits labeled as: PARACERVICAL PUDENDAL BLOCK TR, Pack Number DYNJRA1023

Reason for Recall

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.

Distribution Pattern

Worldwide distribution.

Code Information

DYNJRA1023 , Lot Number 21IBW483 ; DYNJRA1023 , Lot Number 22ABH162 ; DYNJRA1023 , Lot Number 19BBA260 ; DYNJRA1023 , Lot Number 19FBP403 ; DYNJRA1023 , Lot Number 19IBY026 ; DYNJRA1023 , Lot Number 19KBX011 ; DYNJRA1023 , Lot Number 20EBK333 ; DYNJRA1023 , Lot Number 20GBU419 ; DYNJRA1023 , Lot Number 20HBS695 ; DYNJRA1023 , Lot Number 20KBF923