Smoothbore breathing system with exhalation port 22 mm recall
Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing…
Why was Smoothbore breathing system with exhalation port 22 mm recalled?
The device was assembled with the incorrect exhalation port which can cause gas leakage.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: B0062001 Lot Numbers: 4200283 and 4200286 UDI Codes: (01)00081647202239(10)4200286 (01)00081647202239(10)4200283
- Product
- Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing…
- Recalling firm
- Intersurgical Inc
- Quantity
- 200 devices
- Distribution
- All of the devices were shipped to the same distributor (McKesson).
- Recall date
- January 6, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)