Z-2007-2020Class II

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

Name: Z-2007-2020 Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Creator: Edwards Lifesciences, LLC
Published: 2020-03-27
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2020-03-27 / Terminated / root cause: packaging

FDA source

Edwards Lifesciences, LLC began a recall of Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181 on 2020-03-27. FDA classified it as Class II and gives the reason as "Sterile catheter kit packaging compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2007-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-27
Posted: 2020-07-10
Terminated: 2021-04-27
Recalling firm: Edwards Lifesciences LLC
Product: Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Product code: DQE Catheter, Oximeter, Fiber-Optic
Reason for recall: Sterile catheter kit packaging compromised.
Root cause tag: packaging
FDA root cause: Under Investigation by 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.
Quantity in commerce: 597 units
Distribution: US - AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MO, SC, TN, TX and VA.
Product codes and lots: Model: XA3816SFKT LOT CODES: 62563142, 62157774, 62132722, 62749306, 62625932

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2007-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2007-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14

Product code DQE

K172423Class IIPediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)Edwards Lifescience, LLC / cleared 2018-02-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)