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Recall Observatory FDA recall evidence

Device product

Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - 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-1867-2021

April 29, 2021

Class II

Product summary

Firm
Covidien, LP
Event
Event 87925
Status
Ongoing
Classification
Class II
Quantity
7200
Official record key
device-enforcement:Z-1867-2021

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: 20884522033234 GTIN Secondary Package: 10884522033237 Lot Number: 20J0699FAX

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.