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U.S. Department of Health and Human Services

Class 2 Device Recall Intersurgical Breathing Circuit 22mm, nonconductive, single patient use

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  Class 2 Device Recall Intersurgical Breathing Circuit 22mm, nonconductive, single patient use see related information
Date Initiated by Firm April 25, 2018
Create Date June 27, 2018
Recall Status1 Terminated 3 on April 09, 2019
Recall Number Z-2302-2018
Recall Event ID 80250
Product Classification Circuit, breathing (w connector, adaptor, y piece) - Product Code CAI
Product Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000
Code Information 0261604, 0671602, 0671603, 0741609, 0751601 , 0821605, 0821606, 0891605, 0891606, 0951609, 0961601, 1751601 , 0011802, 0011803, 0021803, 0081808 and 0161805.
Recalling Firm/
Manufacturer		 Intersurgical Inc
6757 Kinne St.
E. Syracuse NY 13057
For Additional Information Contact Intersurgical Customer Support
800-828-9633
Manufacturer 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.
FDA Determined
Cause 2		 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 Support@intersurgicalinc.com. 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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