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Open, Classified

Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.

FDA Recall Z-2530-2025 · Posted 2025-09-05

Recalling FirmAVID Medical, Inc.
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2025-08-04
Product Quantity57 units

Reason for Recall

Potential for open header bag seals, compromising sterility.

Firm Action

Owens & Minor notified consignees on about 08/04/2025 via email. Consignees were instructed to discard and discontinue use of all impacted kits. to notify customers if affected units were further distributed, and complete and return the Recall Response Form provided.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide distribution in the state of Florida.

Official Source

View FDA Recall →

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

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