Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 16, 2014
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Rgi Medical Manufacturing, Inc. recalled Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Cathete… - a moderate-severity action.
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Cathete… was recalled by Rgi Medical Manufacturing, Inc. in July 16, 2014. Reason: Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension s…. Check the official notice for the remedy. Verify recall #Z-1996-2014 with the FDA Devices before acting.
The recall
Rgi Medical Manufacturing, Inc. issued this moderate-severity FDA Devices recall-Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension s….
- Moderate
- severity level
- 19K units
- affected scope
- Class II
- classification
- July 16, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1996-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1996-2014) was formally reported on July 16, 2014, with the manufacturer initiating the action on March 28, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Rgi Medical Manufacturing, Inc. is listed as the recalling firm, operating out of Gainesville, FL. Federal records list the affected scope as 19,200 units..
The documented reason for this recall is: Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
19,200 units.
Related Recalls
6
3 from same agency
Product description
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1996-2014 |
| Date reported | July 16, 2014 |
| Date initiated | March 28, 2014 |
| Recalling firm | Rgi Medical Manufacturing, Inc. |
| Firm location | Gainesville, FL |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1996-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.. Recalled by Rgi Medical Manufacturing, Inc.. Units affected: 19,200 units..
Why was this product recalled? ▼
Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 16, 2014. Severity: Moderate. Recall number: Z-1996-2014.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1996-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 16, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.