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Terminated

Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181

FDA Recall Z-2007-2020 · Posted 2020-07-10

Recalling FirmEdwards Lifesciences, LLC
Recall StatusTerminated
Product CodeDQE
Date Initiated2020-03-27
Date Terminated2021-04-27
Product Quantity597 units

Reason for Recall

Sterile catheter kit packaging compromised.

Firm Action

Recall is to the customer level. URGENT MEDICAL DEVICE RECALL- ACTION REQUIRED letter, via FedEx, along with an acknowledgment form will be sent to all customers possessing any of the affected units. Letters will be sent overnight via FedEx. Customers will be instructed to acknowledge the notification, contact the firm at the contact information in the communication to obtain a Returned Goods Authorization (RGA) number, and to return all product to the recalling firm.

Root Cause

Under Investigation by firm

Distribution Pattern

US - AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MO, SC, TN, TX and VA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)Edwards Lifescience, LLC · 2018-02-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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