Z-1962-2021Class II

Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520

Name: Z-1962-2021 Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
Creator: Edwards Lifesciences, LLC
Published: 2021-05-26
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2021-05-26 / Terminated

FDA source

Edwards Lifesciences, LLC began a recall of Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520 on 2021-05-26. FDA classified it as Class II and gives the reason as "There is a potential that the pressure tubing may detach from the blood sampling system". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1962-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-26
Posted: 2021-06-25
Terminated: 2023-12-14
Recalling firm: Edwards Lifesciences LLC
Product: Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
Product code: DXO Transducer, Pressure, Catheter Tip
Reason for recall: There is a potential that the pressure tubing may detach from the blood sampling system
FDA root cause: Under Investigation by firm
Action: On May 26, 2021 Edwards Lifesciences issued a "Urgent Medical Device Recall" Notification via FedEx to all affected consignees. In addition to informing consignees about the recalled product, the firm asked consignees to take the following actions: 1. Action to be taken by user: We request that you return all unused product in your inventory with the model and lot numbered reference above. For product that has been used and will be returned, please contact Customer Service at 1-800-424-3278 to request a biokit. Please review your inventory and quarantine any affected product until prepared for return to Edwards Lifesciences. Please follow the instructions included in the enclosed acknowledgement form an return within 5 days of receipt of this notification. 2. Action to be taken by distributor: Please complete the acknowledgement form and return to [email protected]. Please forward this customer communication to any of your customers who have purchased the impacted Edwards VAMP Jr. and TruWave/VAMP Jr. Products and ask them to return the product toe Edwards with the enclosed acknowledgement form. 3. Alternatively, you can provide Edwards with a list of your customers who have purchased the impacted product and Edwards will communicate directly with your customers to facilitate the recall and acknowledgement process. Please forward your customer list to [email protected] 4. Adverse Event Reporting in the US: - Please contact the FDA's MedWatch Adverse Event reporting program either online, by regular mail, or by fa: Complete and submit the report Online: WWW.fda.gov/medwatch/report.htm - Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 5. Transmission of the Product Recall: This notice need to be passed on to all individuals within your organization who need to be aware of th
Quantity in commerce: 2,000 units
Distribution: US: AZ CA CO CT DC DE FL GA ID IL IN KY LA MA MD ME MI MN MO MS MT NC ND NE NJ PR SD TX UT VA WA WI WV OUS: Canada, United Kingdom, Italy
Product codes and lots: Lot # 63456332

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1962-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1959-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-07	2021-06-25
Z-1960-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-07	2021-06-25
Z-1961-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-07	2021-06-25
Z-1962-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-07	2021-06-25
Z-1963-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-07	2021-06-25
Z-1964-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-07	2021-06-25
Z-1965-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-07	2021-06-25
Z-1966-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-07	2021-06-25

Product code DXO

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)