FDA Medical Device Recalls (openFDA)
Delfi Medical Innovations, Inc.: DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP PROTECTION SLEEVE Rx Only, Sterile
- Recall number
- Z-1902-2020
- 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
- Status
- Terminated
- Initiated
- 2019-04-03
- Posted
- not on file
- Terminated
- 2022-07-22
- Reason
- 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
- 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 grawle@delfimedical.com 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 grawle@delfimedical.com even if those facilities/organizations do not have any affected stock.
- Quantity
- 24 units
- Distribution
- US: Ohio OUS: Austrailia
- Lot, serial or model codes
- 18J15
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KCY
- Firm FEI
- 3003748933
- Firm city
- Vancouver
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28