U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Circuit, breathing (w connector, adaptor, y piece) - Product Code CAI
원인
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.
조치
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.