Class 1 Device Recall smiths medical Pneupac

• Date Initiated by Firm: February 07, 2024
• Date Posted: March 19, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1274-2024
• Recall Event ID: 94089
• 510(K)Number: K123957
• Product Classification: Ventilator, emergency, powered (resuscitator) - Product Code BTL
• Product: smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
• Code Information: Serial Numbers: 24224, 24225, 130135, 220977, 1002250, 1007181, 1007187, 1009159, 1009160, 1009161, 1009162, 1009163, 1009186, 1009187, 1009188, 1009189, 1009190, 1009230, 1009231, 1009232, 1009233, 1009234, 1009235, 1009236, 1009237, 1009238, 1009239, 1010143, 1010144, 1010145, 1010146, 1010147, 1010148, 1010149, 1010150, 1010151, 1010152, 1010167, 1010170, 1010173, 1010174, 1010175, 1010176, 1011339, 1011340, 1011341, 1011342, 1011343, 1011344, 1011345, 1011346, 1011347, 1011348, 1011349, 1011350, 1011351, 1011352, 1011353, 1011354, 1011355, 1011356, 1011357, 1011358, 1011452, 1011453, 1011454, 1011455, 1011456, 1012169, 1012170, 1012171, 1012172, 1012173, 1012174, 1012175, 1012176, 1012177, 1012178, 1012179, 1012180, 1012181, 1012182, 1012183, 1102229, 1102230, 1102231, 1102232, 1102330, 1102331, 1102332, 1102413, 1102414, 1103190, 1103191, 1103226, 1103249, 1103250, 1103251, 1103252, 1103362, 1103388, 1103389, 1103390, 1103391, 1103392, 1104182, 1104183, 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• Recalling Firm/ Manufacturer: Smiths Medical ASD Inc.; 6000 Nathan Ln N; Minneapolis MN 55442-1690
• For Additional Information Contact: 763-383-3072
• Manufacturer Reason for Recall: When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed.
• FDA Determined Cause: Under Investigation by firm
• Action: Smiths medical issued an "URGENT MEDICAL DEVICE CORRECTION" notice to its consignees on 02/07/2024 via letter using traceable means. The notice explained the issue with the device, potential risk to the patient, and requested the following actions be taken: "There is no need to return or discontinue using your paraPAC plus, at this time. When using the device, all instructions, including warnings and cautions in the User Manual Doc. numbers (10018833-003 and/or 10026347-002) must be followed with heightened awareness. This is inclusive, but not limited to the following: " Constant monitoring of the patient. " Blood oxygenation and expired carbon dioxide levels should be monitored independently using pulse oximetry and capnography. " All pre-use checks must be performed before each use. " Alternative means of ventilation such as bag mask ventilation, must be available in the event of ventilator failure or malfunction. If the paraPac plus ventilator experiences continuous flow, remove the ventilator from clinical use, set the device aside for repair and use another device or alternative means of ventilation." " Customer Required Actions: 1. Please identify all paraPAC plusTM units in your possession. 2. Share this recall notification with all potential users of the devices and if the devices are used at another location. 3. Complete and return the attached Customer Response Form to smithsmedical3488@sedgwick.com. 4. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to smithsmedical3488@sedgwick.com." For questions about this Field Correction Notice, contact your sales representative or call 763-383-3072.
• Quantity in Commerce: 10140 units
• Distribution: Worldwide distribution: US (nationwide) and OUS countries of: Algeria, Armenia, Australia, Austria, Bangladesh, Bahrain, Bolivia, Plurinational state of, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Cyprus, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Hong Kong, Iceland, India, Indonesia, Israel, Ireland, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Singapore, Slovakia, Slovenia, Saudi Arabia, South Africa, Spain, Sweden, Tawain, Province of China, Thailand, Trinidad and Tobago, Turkey, United Kingdom and Viet Nam.
• 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 = BTL and Original Applicant = SMITHS MEDICAL INTERNATIONAL LTD.