Z-0753-2021Class II

Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing...

Name: Z-0753-2021 Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing...
Creator: Intersurgical Inc
Published: 2020-11-11
License: https://open.fda.gov/license/

Intersurgical Ltd. / initiated 2020-11-11 / Terminated / root cause: manufacturing process

FDA source

Intersurgical Inc began a recall of Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems -... on 2020-11-11. FDA classified it as Class II and gives the reason as "The device was assembled with the incorrect exhalation port which can cause gas leakage". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0753-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-11
Posted: 2020-12-30
Terminated: 2022-08-09
Recalling firm: Intersurgical Ltd.
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.
Product code: OFP Anesthesia Breathing Circuit Kit (Adult & Pediatric)
Reason for recall: The device was assembled with the incorrect exhalation port which can cause gas leakage.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Recall Strategy and Instruction: 1. Immediately discontinue use and quarantine any stock with the product/lot number described above in this recall notification. 2. If you have distributed any of these products, please immediately contact your customers, advise them of the recall situation and have them return their outstanding recalled stock to you. 3. Complete the Customer Product Recall Acknowledgement Form a. Return the completed form via email to Intersurgical Inc. at [email protected]. b. The subject line should contain Intersurgical Recall: Company name c. Please note: If you do not have the recalled product in stock, please check the appropriate box on the Customer Product Recall Acknowledgement Form. 4. Once we receive your Customer Product Recall Acknowledgement Form, Intersurgical Customer Support will issue a Return Goods Authorization (RGA) Number for the amount of product you have on-hand to return. a. Intersurgical will credit your account when the product is received. Intersurgical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact Customer Support at 800-828-9633 or email at [email protected]. Distribution: Distribution began 09/02/2020 Distributed: 200 pieces
Quantity in commerce: 200 devices
Distribution: All of the devices were shipped to the same distributor (McKesson).
Product codes and lots: Model Number: B0062001 Lot Numbers: 4200283 and 4200286 UDI Codes: (01)00081647202239(10)4200286 (01)00081647202239(10)4200283

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0753-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0753-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-06	2020-12-30

Product code OFP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)