🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: May 22, 2018 NewDeal SA Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Distribution:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2445-2018

Related Recalls

Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765S, 111770S, 111775S, 111780S, 111785S, 111790S, 111795S, 111800S, 111805S, 111810S, 111815S, 111820S, 121740S, 121745S, 121750S, 121755S, 121760S, 121765S, 121770S, 121775S, 121780S, 121785S, 121790S, 121795S, 121800S, 121805S, 121810S, 121815S & 121820S

NewDeal SA

Class I - Dangerous

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.

May 22, 2018 Other Medical Devices View Details →