🔍 RecallPedia

20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)

Class I - Dangerous
🏥 Medical Devices Recalled: March 11, 2022 Abbott Vascular Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Part Numbers: 1000184 Device Identifier-GTIN: 08717648013591 Lot Numbers: 60309678 60320071 60337162 60311336 60320899 60337166 60311338 60331726 60311337 60311339 60331727 60317539 60315914 60334491 60318209 60317535 60334492
  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:
Abbott Vascular
Reason for Recall:
Due to an increase in complaint trend for leaks and intermittent/loose connections.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)

Product Codes/Lot Numbers:

Part Numbers: 1000184 Device Identifier-GTIN: 08717648013591 Lot Numbers: 60309678 60320071 60337162 60311336 60320899 60337166 60311338 60331726 60311337 60311339 60331727 60317539 60315914 60334491 60318209 60317535 60334492

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0921-2022

Related Recalls

20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).

Abbott Vascular

Class I - Dangerous

Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.

Nov 6, 2024 Implants & Prosthetics Nationwide View Details →