FDA Device recall Z-2283-2021
Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile E…
- FDA Device
- Class II
- terminated
- Published 2021-08-18
On 2021-08-18 the FDA classified a Class II recall of Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile E… by Edwards Lifesciences, citing there is a potential for internal leaks within catheters.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2283-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-09 |
| Published | 2021-08-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Edwards Lifesciences |
| Distribution | AZ, CA, FL, IN, MD, MI, NJ, NY, OH, PA, TX, WA |
Product
Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile EO, UDI: (01)00690103197501 *NOT DISTRIBUTED WITHIN THE US
Reason
There is a potential for internal leaks within catheters.
Identifiers
| code_info | Lot Numbers: 62489900, 62505764, 62544663, 62706301, 62714762, 62889054, 62889102, 63091148 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2283-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.