Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure proc
FDA device recall Z-1996-2014 · posted 2014-07-07 · Terminated
Recall details
- Recalling firm
- RGI Medical Manufacturing, Inc.
- Reason for recall
- Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use.
- Action taken
- 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
- Root cause
- Process control
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 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.
- Date initiated
- 2014-03-28
- Date posted
- 2014-07-07
- Date terminated
- 2016-09-29
- Location
- Gainesville, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACTI-FLEX IV ADMINISTRATION SET (K001599) | R-Group Intl. | 2000-09-18 |