| Class 2 Device Recall Intersurgical Superset Double Swivel Elbow and Bronchoscopy Port | |
Date Initiated by Firm | August 07, 2019 |
Create Date | January 08, 2020 |
Recall Status1 |
Terminated 3 on December 15, 2020 |
Recall Number | Z-0786-2020 |
Recall Event ID |
83527 |
510(K)Number | K911421 |
Product Classification |
Connector, airway (extension) - Product Code BZA
|
Product | Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector. |
Code Information |
Lot numbers: 2180531, 2181808, 2182241, 2182533 |
Recalling Firm/ Manufacturer |
Intersurgical Inc 6757 Kinne St East Syracuse NY 13057-1215
|
For Additional Information Contact | 315-451-2900 |
Manufacturer Reason for Recall | The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Intersurgical Inc. issued Urgent Medical Device Recall notices to customers dated August 5, 2019.
Customers were advised to take the following actions:
1. Immediately discontinue use and quarantine any stock with the product/lot number described in the 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. Contact Intersurgical Customer Support at 800-828-9633 for a Return Goods Authorization (RGA) Number. Hours of operation are Monday through Friday,
8:00 a.m. to 4:30 p.m. EST.
a. Once you have received the RGA Number, please enter it in the space provided on the Customer Product Recall Acknowledgement Form:
i. Return the completed form via email to Intersurgical Inc. at support@intersurgicalinc.com.
ii. The subject line should contain your Company name and RGA number.
1. This will allow us to document your receipt of this letter and the amount of product you have on-hand for return.
b. Intersurgical will credit your account when the product is received.
4. Please note: If you do not have the recalled product in stock, please check the appropriate box 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 Intersurgical Recall |
Quantity in Commerce | 19,200 pieces |
Distribution | US Nationwide |
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.
|
510(K) Database | 510(K)s with Product Code = BZA
|
|
|
|