Class 2 Device Recall Mechanical Filter with Connector Small, Tethered Cap

• Date Initiated by Firm: April 29, 2021
• Date Posted: June 16, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1867-2021
• Recall Event ID: 87925
• 510(K)Number: K941536
• Product Classification: Filter, bacterial, breathing-circuit - Product Code CAH
• 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.
• Code Information: GTIN Primary Package: 20884522033234 GTIN Secondary Package: 10884522033237 Lot Number: 20J0699FAX
• Recalling Firm/ Manufacturer: Covidien, LP; 60 Middletown Ave; North Haven CT 06473-3908
• Manufacturer 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.
• FDA Determined Cause: Material/Component Contamination
• Action: 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
• Quantity in Commerce: 7200
• Distribution: Worldwide distribution - US Nationwide distribution in the states of DE, KY, NY, TX, VA, VT, and WA. Global Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CAH and Original Applicant = MALLINCKRODT MEDICAL