Z-1928-2020Class II

Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 -

Name: Z-1928-2020 Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 -
Creator: Edwards Lifesciences, LLC
Published: 2019-10-07
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2019-10-07 / Terminated / root cause: manufacturing process

FDA source

Edwards Lifesciences, LLC began a recall of Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a... on 2019-10-07. FDA classified it as Class II and gives the reason as "Intermittent communication due to inconsistent crimping of connectors onto cables". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1928-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-07
Posted: 2020-05-08
Terminated: 2021-04-27
Recalling firm: Edwards Lifesciences LLC
Product: Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation.
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: Intermittent communication due to inconsistent crimping of connectors onto cables.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On xx/xx/2019, and URGENT MEDICAL DEVICE RECALL-ACTION REQUIRED, letter was sent to customers by FedEx. Customers are instructed to acknowledge this 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 recalling firm.
Quantity in commerce: 35
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, CA, FL, IL, IN and MO, and the countries of Germany, Netherlands, United Kingdom.
Product codes and lots: The cables with the following serial numbers (35) are recalled: 13710131, 13710130, 13710129, 13710115, 13710113, 13710025, 13710027, 13710028, 13710029, 13710030, 13710031, 13710041, 13710043, 13710045, 13710050, 13710051, 13710056, 13710057, 13710058, 13710061, 13710062, 13710063, 13710064, 13710066, 13710069, 13710070, 13710084, 13710086, 13710089, 13710092, 13710093, 13710094, 13710098, 13710099, 13710100.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1928-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1928-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-08

Product code DQK

K163381Class IIHemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry CableEdwards Lifesciences, LLC / cleared 2017-04-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)