Z-2302-2018Class II

Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000

Name: Z-2302-2018 Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000
Creator: Intersurgical Inc
Published: 2018-04-25
License: https://open.fda.gov/license/

Intersurgical Ltd. / initiated 2018-04-25 / Terminated / root cause: design

FDA source

Intersurgical Inc began a recall of Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000 on 2018-04-25. FDA classified it as Class II and gives the reason as "When assembling an HME or Filter on this breathing circuit the tubing may be pushed up and inadvertently cover or block the exhalation port. This could potentially pose a serious health risk to the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2302-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-25
Posted: 2018-06-27
Terminated: 2019-04-09
Recalling firm: Intersurgical Ltd.
Product: Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000
Product code: CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
Reason for recall: When assembling an HME or Filter on this breathing circuit the tubing may be pushed up and inadvertently cover or block the exhalation port. This could potentially pose a serious health risk to the patient.
Root cause tag: design
FDA root cause: Device Design
Action: On April 25, 2018, the firm issued an Urgent Medical Device Recall letter to its distributors. Customers were advised of the product issue and recall. Recall Instructions: 1. Immediately discontinue use and quarantine any stock with the product number B0062000 described above in this recall notification. 2. If you have distributed any of this product, please immediately contact your customers, advise them of the recall situation and have them return their outstanding recalled stock to you. 3. Contact Intersurgical Customer Support at 800-828-9633 for a Return Goods Authorization Number (RGA). Hours of operation are Monday through Friday, 8:00 a.m. to 4:30 p.m. EST. 4. Once you have received the RGA Number, please enter it in the space provided on 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 your Company name and RGA number. i. This will allow us to document your receipt of this letter and the amount of product you have on-hand for return. 5. Intersurgical will credit your account when the product is received. If you have any other questions, feel free to contact Intersurgical Customer Support at 1-800-828-9633.
Quantity in commerce: 1340
Distribution: Distributors in IL, NJ, NV, TX, UT.
Product codes and lots: 0261604, 0671602, 0671603, 0741609, 0751601 , 0821605, 0821606, 0891605, 0891606, 0951609, 0961601, 1751601 , 0011802, 0011803, 0021803, 0081808 and 0161805.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2302-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2302-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-27

Product code CAI

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)