FDA Device recall Z-2007-2020
Sterile Oxymetry Oligon Catheter Kit
- FDA Device
- Class II
- terminated
- Published 2020-05-20
On 2020-05-20 the FDA classified a Class II recall of Sterile Oxymetry Oligon Catheter Kit by Edwards Lifesciences, citing sterile catheter kit packaging compromised.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2007-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-27 |
| Published | 2020-05-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Edwards Lifesciences |
| Distribution | AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MO, SC, TN, TX, VA |
Product
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Reason
Sterile catheter kit packaging compromised.
Identifiers
| code_info | Model: XA3816SFKT LOT CODES: 62563142, 62157774, 62132722, 62749306, 62625932 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2007-2020%22
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