Recall Z-2217-2019

Reason for recall

Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.

FDA-determined cause: Labeling Change Control

Action taken

On March 13, 2019, the firm notified customers via Urgent Medical Device Recall letter. Customers were informed that the kits contain a 15F "non-valved" peelable introducer despite the label indicating that the kit is packaged with a "valved" introducer. Customers were asked to do the following: 1. Immediately examine your inventory and quarantine product subject to recall. 2. If you have further distributed this product, please identify your customers and immediately notify them of the recall. 3. Contact your Medical Components, Inc. customer service representative for a Returned Goods Authorization (RGA) number if you have product to return. The phone number to call is 215-256-4201. 4.Complete and return the Medical Device Recall Return Response Form. The form can be returned by fax (215-256-9191) or email (recalls@medcompnet.com). Contact Information for questions: Monday through Friday, 8:00 AM to 4:00 PM, Eastern Standard Time. Phone: 215-256-4201; Email: recalls@medcompnet.com