Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197525 *NOT DISTRIBUTED WITHIN THE US
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot numbers: 62685542, 62685542, 63316354, 62685542, 62704123, 62685542, 62685542, 62667413, 62685542, 62704123, 62685542, 63608316, 62685542, 62704123, 62685542, 62685542, 62704123, 62685542, 62685542
- 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:
- Edwards Lifesciences, LLC
- Reason for Recall:
- There is a potential for internal leaks within catheters.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197525 *NOT DISTRIBUTED WITHIN THE US
Product Codes/Lot Numbers:
Lot numbers: 62685542, 62685542, 63316354, 62685542, 62704123, 62685542, 62685542, 62667413, 62685542, 62704123, 62685542, 63608316, 62685542, 62704123, 62685542, 62685542, 62704123, 62685542, 62685542
Distribution:
Distributed in: US, CA, TX, FL, AZ, PA, IN, NY, NJ, MI, WA, MD, OH
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2281-2021
Related Recalls
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.