Recall Z-1274-2024
Smiths Medical ASD Inc. · initiated February 7, 2024
Class I – dangerous or defective products that could cause serious health problems or death
Product
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
Codes / lots: 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, 1104184, 1104185, 1104186, 1104187, 1104188, 1104189, 1104190, 1104191, 1104279, 1104280, 1104291, 1104292, 1104293, 1104320, 1104321, 1104322, 1104323, 1104324, 1105182, 1105209, 1105210, 1105211, 1105212, 1105213, 1105214…
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 taken
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.
Details
- Recall number
- Z-1274-2024
- Initiated
- February 7, 2024
- Posted by FDA
- March 19, 2024
- Product code
- BTL – Ventilator, Emergency, Powered (Resuscitator)
- Quantity
- 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…
- Recalling firm
- Smiths Medical ASD Inc., Minneapolis, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1275-2024 Class I | smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUSWhen a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may… | 02/07/2024Open, Classified |