Recall Z-0784-2020

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: Under Investigation by firm

Action taken

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