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Recall Observatory FDA recall evidence

Device product

PVP SOLUTION SING STRL, REF DYNDA1858

Z-0529-2024

November 03, 2023

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 93395
Status
Ongoing
Classification
Class II
Quantity
1950 units
Official record key
device-enforcement:Z-0529-2024

Official wording

Reason: The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.

Code information: UDI/DI 40889942539858 (case), 10889942539857 (each), Lot numbers: 2023032090, 2023020990, 2022103190, 2022091690, 2022070190, 2022052090, 2022042290, 2022033190, 2021102290, 2021092190

Distribution pattern: US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.