DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model No. 25009; Product UPN 20613994918608; Lot No. 2016090217, 2016091068, 2016100893, 2016110439, 2016120464, 2017010278, 2017030102, 2017030576, 2017031125. Model No. 25010: Product UPN 20613994918585: Lot No. 2016020841, 2016031522, 2016050255, 2016070494, 2016081243, 2016090923, 2016110054, 2016110837, 2017040714.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Medtronic Perfusion Systems
- Reason for Recall:
- Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
Product Codes/Lot Numbers:
Model No. 25009; Product UPN 20613994918608; Lot No. 2016090217, 2016091068, 2016100893, 2016110439, 2016120464, 2017010278, 2017030102, 2017030576, 2017031125. Model No. 25010: Product UPN 20613994918585: Lot No. 2016020841, 2016031522, 2016050255, 2016070494, 2016081243, 2016090923, 2016110054, 2016110837, 2017040714.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2767-2017
Related Recalls
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
Medtronic Perfusion Systems
Certain lots of product have the potential for a sterile barrier breach.
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter
Medtronic Perfusion Systems
Certain lots of product have the potential for a sterile barrier breach.
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter
Medtronic Perfusion Systems
Certain lots of product have the potential for a sterile barrier breach.