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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Lot Codes / Batch Numbers
GTIN Primary Package: 20884522033234 GTIN Secondary Package: 10884522033237 Lot Number: 20J0699FAX
Products Sold
GTIN Primary Package: 20884522033234 GTIN Secondary Package: 10884522033237 Lot Number: 20J0699FAX
A medical device manufacturer is recalling Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated due to The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters fo. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026