Class 1 Device Recall Smiths Medical

• Date Initiated by Firm: May 31, 2024
• Date Posted: September 20, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3091-2024
• Recall Event ID: 94974
• 510(K)Number: K123957
• Product Classification: Ventilator, emergency, powered (resuscitator) - Product Code BTL
• Product: paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
• Code Information: Serial Numbers: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 234, 235, 243, 244, 245, 246, 247, 248, 249, 250, 251, 252, 259, 260, 261, 262, 263, 264, 265, 266, 267, 268, 269, 270, 271, 272, 273, 274, 275, 276, 277, 278, 279, 280, 281, 282, 283, 284, 285, 286, 287, 288, 289, 290, 291, 292, 293, 294, 295, 296, 297, 298, 299, 300, 301, 302, 303, 304, 70085, 70091, 70096, 70097, 70101, 70103, 70111, 70112, 70114, 70119, 70142, 70171, 70299, 1007188, 1102432, 1102433, 1206210, 1206211, 1206212, 1206213, 1206214, 1206235, 1206236, 1206237, 1206238, 1210164, 1210165, 1210166, 1303220, 1303228, 1303229, 1303230, 1303231, 1303232, 1303233, 1303234, 1304223, 1304224, 1304225, 1304226, 1304227, 1304228, 1304229, 1304230, 1304231, 1304232, 1304233, 1304234, 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RF70280, RF70281, RF70282, RF70283, RF70284, RF70287, RF70289, RF70292, RF70293, RF70296, RF70298
• FEI Number: 3012307300
• 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: Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.
• FDA Determined Cause: Other
• Action: Smiths Medical issued an URGENT MEDIC AL DEVICE CORRECTION notice to its consignees on05/31/2024 via letter. The notice explained the issue, potential risk, and requested the following: "Perform an inspection to determine if your devices are affected, per the instructions below: a. First perform a visual inspection to determine if the outlet connector is disconnected. b. Second evaluate the connector physically to determine if the outlet connector is loose or moves when placing a patient circuit on the connector or when removing it. c. If outlet connector remains tight after physical inspection, you can continue use of the device with heightened awareness and following all pre-use checks as per the user manual. d. If the outlet connector moves or feels loose, the device must be removed from use and repaired by Smiths Medical. Report the event to Global Complaint Management at globalcomplaints@icumed.com. Every use thereafter of every device, pre-use checks must be completed as described in the user manual and extra caution must be taken in inspecting the outlet connector prior to use and placing the patient circuit on the connector and during removal. Share this recall notification with all potential users of the devices to ensure they are aware of this recall and proposed mitigations." Those distributing the affected devices were directed to notify those to whom the devices were distributed. Device Correction Inquiries: contact - https://icumed.custhelp.com/app/marketaction
• Quantity in Commerce: 3182 units
• Distribution: Worldwide 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 = BTL