Z-1867-2021 Class II Ongoing
FDA device recall Z-1867-2021 was initiated by Covidien, LP on April 29, 2021 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 7200.
Recall Details
- Product Type
- Devices
- Report Date
- June 23, 2021
- Initiation Date
- April 29, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7200
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of DE, KY, NY, TX, VA, VT, and WA. Global Distribution.
Code Information
GTIN Primary Package: 20884522033234 GTIN Secondary Package: 10884522033237 Lot Number: 20J0699FAX