Drug recall
Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm…
FDA recall event 88270 · Class II · Edwards Lifesciences, LLC
Key facts
| Event ID | 88270 |
|---|---|
| Recall numbers | Z-2278-2021, Z-2279-2021, Z-2280-2021, Z-2281-2021, Z-2282-2021, Z-2283-2021 |
| Recalling firm | Edwards Lifesciences, LLC |
| Product type | Devices |
| Products | Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO…, Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI…, Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO, UDI: (01)00690103197495 *NOT DISTRIBUTED WITHIN THE US, 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, Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI… and 1 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a potential for internal leaks within catheters. |
| Initiation date | Jul 9, 2021 |
| Report date | Aug 18, 2021 |
| Termination date | Jan 29, 2024 |
| City | Irvine |
| State | CA |
| Country | United States |
| FEI number | 2015691 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: