Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Reported: May 20, 2020 Initiated: March 27, 2020 #Z-2007-2020
Product Description
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Reason for Recall
Sterile catheter kit packaging compromised.
Details
- Recalling Firm
- Edwards Lifesciences, LLC
- Units Affected
- 597 units
- Distribution
- US - AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MO, SC, TN, TX and VA.
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181. Recalled by Edwards Lifesciences, LLC. Units affected: 597 units.
Why was this product recalled? ▼
Sterile catheter kit packaging compromised.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 20, 2020. Severity: Moderate. Recall number: Z-2007-2020.
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