Z-1902-2020Class II

DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP...

Name: Z-1902-2020 DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP...
Creator: Delfi Medical Innovations, Inc.
Published: 2019-04-03
License: https://open.fda.gov/license/

Delfi Medical Innovations, Inc. / initiated 2019-04-03 / Terminated / root cause: manufacturing process

FDA source

Delfi Medical Innovations, Inc. began a recall of DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP PROTECTION SLEEVE Rx Only, Sterile on 2019-04-03. FDA classified it as Class II and gives the reason as "Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFit Sterile Single Use Thigh Cuffs, Single Port, Single Bladder models may have been manufactured with an inadequate...". 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-1902-2020
Classification: Class II
Status: Terminated
Initiated: 2019-04-03
Posted: 2020-05-06
Terminated: 2022-07-22
Recalling firm: Delfi Medical Innovations, Inc.
Product: DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP PROTECTION SLEEVE Rx Only, Sterile
Product code: KCY Tourniquet, Pneumatic
Reason for recall: Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFit Sterile Single Use Thigh Cuffs, Single Port, Single Bladder models may have been manufactured with an inadequate perimeter weld on the cuff. Once applied to a patients thigh and inflated to a pressure to occlude blood flow in the thigh distal to the cuff, after a period of time the cuff may leak to the extent that the tourniquet instrument supplying air pressure to the cuff may not be able to adequately control and regulate pressure in the cuff. This may result in some blood flow in the thigh distal to the cuff.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 4/3/2019, Delfi Medical Innovations sent a recall notification via E-Mail to consignees informing them about the recall. In addition, to informing consignees about the recall, the firm asked customers to take the following actions: 1. Communicate this notice to all those in your organization who need to be aware of its contents. 2. If your organization supplied or transferred any potentially affected product to another facility or organization, inform that facility/organization of the recall by providing a copy of this notice and the attached Customer Acknowledgement form. 3. Inspect your organization's stock and quarantine affected stock on hand to prevent further use. 4. Recover all quarantined quantities of the identified products in your organization's possession and from customers to which you distributed products and return them to Delfi for full credit and at Delfi's expense. 5. Complete the attached Customer Acknowledgement Form and email to Gail Rawle at [email protected] even if your organization does not have any affected stock. 6. If your organization supplied or transferred any potentially affected product to another facility or organization, email those facilities/organization completed Customer Acknowledgement Forms to Gail Rawle at [email protected] even if those facilities/organizations do not have any affected stock.
Quantity in commerce: 24 units
Distribution: US: Ohio OUS: Austrailia
Product codes and lots: 18J15

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1902-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1901-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-05
Z-1902-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-05

Product code KCY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)