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U.S. Department of Health and Human Services

Class 2 Device Recall Intersurgical Superset Double Swivel Elbow and Bronchoscopy Port

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 Class 2 Device Recall Intersurgical Superset Double Swivel Elbow and Bronchoscopy Portsee related information
Date Initiated by FirmAugust 07, 2019
Create DateJanuary 08, 2020
Recall Status1 Terminated 3 on December 15, 2020
Recall NumberZ-0787-2020
Recall Event ID 83527
510(K)NumberK911421 
Product Classification Connector, airway (extension) - Product Code BZA
ProductSuperset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airway connector.
Code Information Lot numbers:  2182536, 2182852, 2183161, 2190350, 2190531, 2190617, 2191025, 2191591
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
ActionIntersurgical 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 Commerce50,400 pieces
DistributionUS Nationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = BZA
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