Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 2, 2015
Central Line >34 Weeks Kit . Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids, nutrients, or blood products over a long period of time, usually several weeks or more. A catheter is often inserted in the arm or chest through the skin into a large vein. The catheter is threaded through this vein until
The print plate artwork for this lot was found to state: Central Line <34 Weeks Kit displaying an incorrect sign in front of the 34. The description for this device should have …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medline Industries Inc recalled Central Line >34 Weeks Kit . Cardiology department. The Central Line >34 Weeks Kit (DYND… - a moderate-severity action.
Central Line >34 Weeks Kit . Cardiology department. The Central Line >34 Weeks Kit (DYND… was recalled by Medline Industries Inc in September 2, 2015. Reason: The print plate artwork for this lot was found to state: Central Line <34 Weeks Kit displaying an incorrect…. Check the official notice for the remedy. Verify recall #Z-2458-2015 with the FDA Devices before acting.
The recall
Medline Industries Inc issued this moderate-severity FDA Devices recall-The print plate artwork for this lot was found to state: Central Line <34 Weeks Kit displaying an incorrect….
- Moderate
- severity level
- 320 units
- affected scope
- Class II
- classification
- September 2, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2458-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2458-2015) was formally reported on September 2, 2015, with the manufacturer initiating the action on August 3, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Medline Industries Inc is listed as the recalling firm, operating out of Mundelein, IL. Federal records list the affected scope as 320 units for lot 14DB9277 & 320 units for lot 14PB2878.
The documented reason for this recall is: The print plate artwork for this lot was found to state: Central Line <34 Weeks Kit displaying an incorrect sign in front of the 34. The description for this device should have stated Central Line >34 Weeks Kit. The… Distribution data in the federal record shows the product reached: US including PA. 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
320 units for lot 14DB9277 & 320 units for lot 14PB2878
Related Recalls
6
3 from same agency
Product description
Central Line >34 Weeks Kit . Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids, nutrients, or blood products over a long period of time, usually several weeks or more. A catheter is often inserted in the arm or chest through the skin into a large vein. The catheter is threaded through this vein until it reaches a large vein near the heart.
Reason for recall
The print plate artwork for this lot was found to state: Central Line <34 Weeks Kit displaying an incorrect sign in front of the 34. The description for this device should have stated Central Line >34 Weeks Kit. The defect may lead to the product to be used on patient population that is <34 weeks rather than intended population of >34 weeks.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2458-2015 |
| Date reported | September 2, 2015 |
| Date initiated | August 3, 2015 |
| Recalling firm | Medline Industries Inc |
| Firm location | Mundelein, IL |
| Affected scope | 320 units for lot 14DB9277 & 320 units for lot 14PB2878 |
| Distribution | US including PA |
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-2458-2015) 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? ▼
Central Line >34 Weeks Kit . Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids, nutrients, or blood products over a long period of time, usually several weeks or more. A catheter is often inserted in the arm or chest through the skin into a large vein. The catheter is threaded through this vein until it reaches a large vein near the heart.. Recalled by Medline Industries Inc. Units affected: 320 units for lot 14DB9277 & 320 units for lot 14PB2878.
Why was this product recalled? ▼
The print plate artwork for this lot was found to state: Central Line <34 Weeks Kit displaying an incorrect sign in front of the 34. The description for this device should have stated Central Line >34 Weeks Kit. The defect may lead to the product to be used on patient population that is <34 weeks rather than intended population of >34 weeks.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 2, 2015. Severity: Moderate. Recall number: Z-2458-2015.
Where was the recalled product distributed? ▼
Distribution: US including PA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2458-2015) 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 September 2, 2015. 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.