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U.S. Department of Health and Human Services

Class 2 Device Recall Intersurgical Double Swivel Elbow with Bronchoscopy Port

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  Class 2 Device Recall Intersurgical Double Swivel Elbow with Bronchoscopy Port see related information
Date Initiated by Firm August 07, 2019
Create Date January 08, 2020
Recall Status1 Terminated 3 on December 15, 2020
Recall Number Z-0785-2020
Recall Event ID 83527
510(K)Number K911425  
Product Classification Connector, airway (extension) - Product Code BZA
Product Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030. Airway connector.
Code Information Lot numbers:  2180448, 2180742, 2181001
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 46,450 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 and Original Applicant = INTERSURGICAL, INC.
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