FDA Medical Device Recalls (openFDA)
Rymed Technologies, Inc.: RYM-5001 InVision-Plus Neutral Displacement I.V. Connector, packaged 100 units per box, 5 boxes per case (500 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico for Rymed Technologies, Inc., Austin, TX.
- Recall number
- Z-0321-2007
- Recalling firm
- Rymed Technologies, Inc.
- Product
- RYM-5001 InVision-Plus Neutral Displacement I.V. Connector, packaged 100 units per box, 5 boxes per case (500 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico for Rymed Technologies, Inc., Austin, TX.
- Status
- Terminated
- Initiated
- 2006-05-25
- Posted
- 2006-12-30
- Terminated
- 2007-03-26
- Reason
- Weld failures on IV connector (area of female luer and spike body)
- Root cause
- Other
- Action
- Consignees were notified by e-mail and/or phone on 05/25/06 regarding the recall. Distributors were asked to return product.
- Quantity
- 28,479 units.
- Distribution
- Nationwide Recall
- Lot, serial or model codes
- Lots #500, 502, 503, 504 and 505.
- 510(k) numbers
- ["K991653"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3005951712
- Firm city
- Austin
- Firm state
- TX
- 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