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Open, Classified

Medline Leg bag, REF URO12573

FDA Recall Z-0535-2024 · Posted 2024-09-30

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeFAQ
Date Initiated2023-10-19
Product Quantity144 devices

Reason for Recall

Undeclared latex

Firm Action

Medline issued a recall notice to its consignees on 10/16/2023 by USPS First Class Mail. The notice explained the issue, potential risk user, and requested destruction of the affected product at the consignee. Anyone who further distributed the product is directed to notify those to whom the product was distributed.

Root Cause

Labeling mix-ups

Distribution Pattern

US and Panama

Official Source

View FDA Recall →

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

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