medical MODERATE Updated 2021-01-06

Intersurgical Inc recalls Smoothbore breathing system with exhalation port 22 mm Devic

See all recalls from Intersurgical Inc →

Recalled Product

Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems - Product Usage: intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.

Share this recall: Facebook X / Twitter WhatsApp Email

Hazard / Issue

The device was assembled with the incorrect exhalation port which can cause gas leakage.

Issued by

FDA

Distribution: All of the devices were shipped to the same distributor (McKesson).
Lot/Code Info: Model Number: B0062001 Lot Numbers: 4200283 and 4200286 UDI Codes: (01)00081647202239(10)4200286 (01)00081647202239(10)4200283

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
View official government recall