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Open, Classified

STERILE PVP, REF DYNDA1649

FDA Recall Z-0528-2024 · Posted 2023-12-11

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2023-11-03
Product Quantity700 units

Reason for Recall

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.

Firm Action

Medline Industries notified its consignees on 11/03/2023 via by email and US Mail (first class). The notice explained the issue and requested the destruction of any affected inventory. Distributor were directed to notify their customers.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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