FDA Medical Device Recalls (openFDA)
RGI Medical Manufacturing, Inc.: Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
- Recall number
- Z-1996-2014
- Recalling firm
- RGI Medical Manufacturing, Inc.
- Product
- Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
- Status
- Terminated
- Initiated
- 2014-03-28
- Posted
- 2014-07-07
- Terminated
- 2016-09-29
- Reason
- Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use.
- Root cause
- Process control
- Action
- RGI Medical Manufacturing, Inc. phoned their direct account: Baxter Healthcare on February 28, 2014 and sent an Urgent: Device Recall letter dated March 21, 2014. The letter identified the affected product, problem and the actions to be taken. Contact 800-747-6870 to obtain instruction for returning the product to RGI
- Quantity
- 19,200 units.
- Distribution
- US Nationwide Distribution in the states of AL, CA, DE, GA, IL, KY, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, TN, TX, WA, and WI.
- Lot, serial or model codes
- Lot numbers 102131 and 110531.
- 510(k) numbers
- ["K001599"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3004994611
- Firm city
- Gainesville
- Firm state
- FL
- Firm country
- not on file
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