NewDeal SA: ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S & 181023S

Recall number

Z-2445-2018

Recalling firm

NewDeal SA

Product

ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S & 181023S

Status

Terminated

Initiated

2018-05-22

Posted

2018-07-16

Terminated

2019-11-04

Reason

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.

Root cause

Packaging change control

Action

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 .

Quantity

not on file

Distribution

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

Lot, serial or model codes

181051S - Lot # FCK9, FG3H & FG3J 181052S - Lot # E8PA/G & EB1H/G 181041S - Lot # F0AS, F0AT & F0AU 181042S - Lot # E8P8/G & EB1F/G 181031S - Lot # E8N2/G, E8NL/G, E8P4/G, E8PS/G, EBKW/G, EBKW/G1 & F8EH 181032S - Lot # E8P5/G, E8P5/G1, E8PT/G, EB1C/G, EBKX/G & F8EJ 181033S - Lot # E8PU/G 181021S - Lot # E8NH/G & E8P1/G-EB18/G 181022S - Lot # E8MF/G, E8MF/G/Q, E8PQ/G & EBKU/G 181023S - Lot # E8MG/G, E8P3/G, E8PR/G & F8EG

510(k) numbers

["K093914"]

PMA numbers

not on file

Product code

HRS

Firm FEI

3002952164

Firm city

St Priest

Firm state

not on file

Firm country

France

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy