SunMed Holdings LLC recalled its Grownup Guide Resuscitator units as a consequence of a producing difficulty the place the B/V filter was assembled onto the affected person port as an alternative of the exhalation port. This incorrect configuration might lead to a delay in remedy throughout emergency use, in accordance with an FDA alert.
The guide resuscitator is used to offer emergency respiratory help to grownup sufferers. It features a face masks, bag reservoir, filter, manometer, and oxygen tubing, and is used throughout conditions resembling cardiac arrest or respiratory failure to manually ship breaths.
In keeping with the FDA, the usage of affected product might trigger severe antagonistic well being penalties, together with lack of oxygen to the physique (hypoxia), build-up of carbon dioxide within the blood (hypercapnia), organ failure, and dying.
There have been no reported accidents. There have been no studies of dying.
Affected Product
- Product Names: Grownup Guide Resuscitator with Medium Grownup Masks, Bag Reservoir, Filter, Manometer and seven ft Oxygen Tubing
- Distinctive Gadget Identifier (UDI)/Mannequin: Every: 10884389164822, Case: 40884389164823
- Lot/Serial Numbers: 526782, 526790, 526796, 526797, 526798, 526800, 526802, 526804, 526805, 526806, 26807, 526808, 526809, 526810, 526814, 526815, 526816, 526811, 526817, 526818
FDA Suggestions:
- Cease utilizing and quarantine all affected product instantly.
- Doc amount readily available and prepare to return or destroy affected models.
On Might 1, 2025, SunMed Holdings, LLC despatched all affected clients an Pressing Medical Gadget Recall discover recommending the next actions:
- Examine your stock for the affected product.
- Cease utilizing the product instantly and quarantine it.
- Doc the quantity of product readily available and return or destroy affected models.
- Distribute the recall discover to any clients who obtained the product from you.
- Full and return response type by way of e-mail to [email protected] as quickly as doable.
- In the event you want pressing help or alternative, contact SunMed immediately.
- Notify all affected personnel in your group of recall.
