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Open, Classified

VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS

FDA Recall Z-1688-2022 · Posted None

Recalling FirmStradis Healthcare
Recall StatusOpen, Classified
Product CodeOXQ
Date Initiated2022-05-10
Product Quantity520 units

Reason for Recall

Potential for incomplete seals.

Firm Action

Stradis notified its sole consignee initially by telephone on 05/10/2022 and followed with a letter disseminated by email on 05/11/2022. The letter explained the problem, risk to health, and requested the quarantine of the affected product pending return. The letter directed the consignee to notify their customers to whom they further distributed the product to return the product to Stradis.

Root Cause

Other

Distribution Pattern

Pennsylvania

Official Source

View FDA Recall →

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

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