Covidien Respiratory Filters Recalled for Sterilization Process Deviations
Covidien is recalling Adult-Pediatric Electrostatic Filter HMEs due to potential deviations in ethylene oxide sterilization parameters. Approximately 192,000 units were distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Sterilization process deviations on medical devices used in high-risk settings (anesthetized and respiratory care patients) represent a risk-of-harm product. No illnesses or injuries have been reported, placing this at the High level per the rubric.
Plain-English summary
Covidien, LP is recalling Adult-Pediatric Electrostatic Filter HMEs (Item Code 352/5877Z) because the company was notified by their sterilization service supplier of potential deviations from validated ethylene oxide sterilization parameters. These filters are single-use medical devices indicated for use with anesthetized patients and respiratory care patients requiring ISO-standard 15mm or 22mm breathing circuit connectors.
Approximately 192,000 affected units were distributed worldwide, including distribution in the United States in Delaware, Kentucky, New York, Texas, Virginia, Vermont, and Washington. Affected lot numbers include 20C1164FAX, 20C1165FAX, 20C1166FAX, 20C1235FAX, 20C1236FAX, 20D1187FAX through 20D1191FAX, 20D1429FAX, 20D1430FAX, 20D1432FAX, 20D1433FAX, 20D1523FAX through 20D1528FAX, 20E0158FAX through 20E0165FAX, 20E0390FAX, 20E0391FAX, 20E0392FAX, 20E0393FAX, 20E0871FAX, 20E0873FAX, 20E0874FAX, 20E0875FAX, 20E0935FAX, 20E0936FAX, 20E0997FAX, and 20E0998FAX.
The recalled product
- Product
- Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - 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.
- Manufacturer
- Covidien, LP
- Affected units
- 192,000
Distribution
Part of a larger recall action
This product is one of 4 recalled by Covidien, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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