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.
Recall
- Recall Number
- Z-1868-2021
- Event Number
- 87925
- FEI Number
- 1219930
- Product Code
- CAH
- Status
- Open, Classified
- Root Cause
- Material/Component Contamination
- Initiated
- April 29, 2021
- Posted
- June 16, 2021
- Address
- LP 60 Middletown Ave, Covidien, North Haven, CT, 06473-3908
Description
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.
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.
An Urgent Medical Device Field Safety Notice dated 4/29/21 was sent to customers. Actions you should take: 1. Immediately quarantine and discontinue use of item codes with associated lot numbers listed in Attachment A. 2. If you have distributed the devices listed in Attachment A, please promptly forward the information from this letter to those recipients. Actions being taken by Medtronic: 1. Medtronic is investigating the sterilization records for affected production lots to determine whether sterilization has been achieved despite the deviations. 2. Medtronic will communicate with affected customers regarding the finding of our investigation once complete and will provide direction on what customers should do with the devices quarantined because of this Field Safety Notice. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2. An URGENT MEDICAL DEVICE WITHDRAWAL notification letter dated 7/12/21 was sent to customers. Medtronic has concluded its investigation of potential deviations in the ethylene oxide sterilization processes performed by Steril Milano, the former supplier of our sterilization services for the DAR" airway products. Medtronic analyzed the available sterilization data and conducted validation tests on production lots where data was available. For products where sterilization process data was available and testing could be conducted, we determined that sterilization of those devices was achieved. However, because there was not a consistent controlled process at the sterilization facility, we are issuing a withdrawal of the production lots of the DAR" airway products which are currently under quarantine at your facility. Required Actions: 1. Please return affected product listed on Attachment A as indicated below. All unu
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