Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 EO, UDI: (01)00690103197501 *NOT DISTRIBUTED WITHIN THE US

U.S. FDA — Device Enforcement · United States · 2021-07-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2283-2021
Date of alert
2021-07-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Edwards Lifesciences, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
62489900
Reported risk: There is a potential for internal leaks within catheters.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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