UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S,

FDA device recall Z-2443-2018 · posted 2018-07-16 · Terminated

Recall details

Recalling firm

NewDeal SA

Reason for recall

Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.

Action taken

On May 22, 2018 Newdeal SAS, a company of Integra LifeSciences, issued URGENT VOLUNTARY MEDICAL DEVICE RECALL notices to their customers. On October 22, 2018 URGENT VOLUNTARY MEDICAL DEVICE RECALL notices were issued to additional customers. Customers were advised to take the following actions: 1. Examine your inventory to determine if you have any affected lots in original product packaging identified within the notice. 2. If you do have any of the affected lots in original product packaging, stop using the product immediately, remove them from service and place in quarantine until the product can be returned. 3. Complete the Acknowledgement and Return Form and check the box: I do have affected products on the list and record the lot number. 4. Or, complete the attached Acknowledgement and Return Form and check the box: I do not have affected products. 5. Complete the other information on the form as indicated on the form. Keep a copy of the form for your records. Return the completed Acknowledgement and Return Form by email or fax indicating your receipt and review of the notification. Customers with questions regarding the instructions, please contact Customer Service at 1-800-654-2873 Monday to Friday 8:00 AM 8:00 PM EST or custsvcnj@integralife.com .

Root cause

Packaging change control

Status

Terminated

Product code

HRS

Distribution

CA, CO, CT, ID, KS, MA, MD, MN, MO, MS, NC, NY, OH, OR, PA, SD, VA, WA & WI

Date initiated

2018-05-22

Date posted

2018-07-16

Date terminated

2019-11-04

Location

St Priest, France

Related 510(k) clearances