RT’s Three Key Takeaways:
- Air flow Challenge Recognized – Mercury Medical is recalling the Neo-Tee T-Piece resuscitator on account of a faulty spring within the controller which will stop the system from delivering enough stress for efficient air flow.
- FDA’s Most Critical Recall Classification – The FDA has categorised this recall as its most severe kind, warning that use of the affected gadgets may result in low oxygen ranges, sluggish coronary heart charge, excessive carbon dioxide ranges, or dying in pediatric sufferers.
- Speedy Motion Required – Mercury Medical has instructed clients to cease use, quarantine affected gadgets, and notify all personnel who might have used or distributed the recalled merchandise.
Mercury Enterprises Inc, doing enterprise as Mercury Medical, is recalling the Neo-Tee T-Piece resuscitator on account of a small spring within the controller which will stop the system from delivering the required stress ranges wanted for efficient air flow. This difficulty may scale back optimistic stress, affecting the affected person’s respiration help.
This recall includes eradicating sure gadgets from the place they’re used or bought. The US Meals and Drug Administration has recognized this recall as probably the most severe kind. The usage of the affected product might trigger severe hostile well being penalties, together with low oxygen ranges, sluggish coronary heart charge, lack of oxygen, excessive carbon dioxide ranges, and dying. There have been no reported accidents or dying related to this difficulty.
The Neo-Tee T-Piece resuscitator is a gas-powered emergency resuscitator supposed to offer emergency respiratory help by the use of a facemask or a tube inserted right into a affected person’s airway. It’s supposed to be used with pediatric sufferers weighing lower than 10kg (22lbs). The system is designed with an in-line circulation controller within the circuit.
On Dec 5, 2024, Mercury Medical despatched all affected clients an Pressing Subject Security Discover recommending the next actions:
- Instantly test the stock for affected product inside the scope of this recall
- Cease use and distribution and instantly quarantine the affected product.
- Present a duplicate of this recall discover to all clients who’ve obtained impacted product. Notify all personnel topic to utilizing these gadgets.
Full checklist of affected gadgets:
Half Quantity | Distinctive System ID | Lot Quantity(s) |
1050805 | 10641043508053, 30641043508057 | 2421450805, 2423550805, 2423650805, 2426750805 |
1050808 | 10641043508084, 30641043508088 | 2426450808, 2426750808, 2426850808, 2429050808, 2429350808 |
1050809 | 10641043508091, 30641043508095 | 2426450809, 2426750809, 2429050809, 2429150809, 2429350809, 2429750809, 2429850809, 2430050809, 2430250809 |
1050810 | 10641043508107, 30641043508101 | 2426750810, 2429350810, 2429750810, 2429850810, 2430250810 |
1050811 | 10641043508114, 30641043508118 | 2426550811, 2426650811, 2426750811, 2429050811, 2429150811, 2429250811, 2429350811, 2429450811, 2429750811, 2429850811, 2429950811, 2430250811 |
1050814 | 10641043508145, 30641043508149 | 2426450814, 2426750814, 2429050814, 2429750814, 2430250814, |
1050832 | 10641043508329, 30641043508323 | 2429050832, 242985083 |
1050839 | 10641043508398, 30641043508392 | 2430350839 |
1050840 | 10641043508404, 30641043508408 | 2429050840, 2429750840 |
1050841 | 10641043508411, 30641043508415 | 2429050841 |
1050842 | 10641043508428, 30641043508422 | 2426750842 |
Clients within the US with questions on this recall ought to contact Mercury Medical at 1-727-573-0088.
