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Recall Observatory FDA recall evidence

Device product

Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.

Z-1866-2021

April 29, 2021

Class II

Product summary

Firm
Covidien, LP
Event
Event 87925
Status
Ongoing
Classification
Class II
Quantity
32625
Official record key
device-enforcement:Z-1866-2021

Official wording

Reason: The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.

Code information: GTIN Primary Package: 40884522012981 GTIN Secondary Package: 30884522012984 Lot Numbers: 20G1304FAX 20G1305FAX 20L0026FAX 20L0027FAX 20L0410FAX 20L0411FAX 20L0412FAX

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of DE, KY, NY, TX, VA, VT, and WA. Global Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.