paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA device recall Z-3090-2024 · posted 2024-09-20 · Open, Classified
Recall details
- Recalling firm
- Smiths Medical ASD Inc.
- 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.
- Action taken
- 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
- Root cause
- Other
- Status
- Open, Classified
- Product code
- BTL
- Quantity affected
- 11244 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2024-05-31
- Date posted
- 2024-09-20
- Location
- Minneapolis, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PNEUPAC PARAPAC PLUS (K123957) | Smiths Medical International , Ltd. | 2013-09-16 |