Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-3014-2024

April 08, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94583
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-3014-2024

Official wording

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 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

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.