Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported September 18, 2024
Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. Please refer to the applicable catheter Instructions for Use for directions on the use of these accessories.
Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the dis…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Bard Peripheral Vascular Inc recalled Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with … - a moderate-severity action.
Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with … was recalled by Bard Peripheral Vascular Inc in September 18, 2024. Reason: Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such…. Check the official notice for the remedy. Verify recall #Z-3062-2024 with the FDA Devices before acting.
The recall
Bard Peripheral Vascular Inc issued this moderate-severity FDA Devices recall-Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such….
- Moderate
- severity level
- 625 units
- affected scope
- Class II
- classification
- September 18, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3062-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-3062-2024) was formally reported on September 18, 2024, with the manufacturer initiating the action on July 10, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Bard Peripheral Vascular Inc is listed as the recalling firm, operating out of Tempe, AZ. Federal records list the affected scope as 625 units.
The documented reason for this recall is: Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the distal end of the hoop. Injury could occur … Distribution data in the federal record shows the product reached: Worldwide - U.S. Nationwide distribution in the states of OH, TX, and WV. The countries of Belgium, Canada, France, Italy, and United Kingdom.. 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
625 units
Related Recalls
6
3 from same agency
Product description
Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. Please refer to the applicable catheter Instructions for Use for directions on the use of these accessories.
Reason for recall
Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the distal end of the hoop. Injury could occur if the user attempts to insert the proximal end into the patient.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-3062-2024 |
| Date reported | September 18, 2024 |
| Date initiated | July 10, 2024 |
| Recalling firm | Bard Peripheral Vascular Inc |
| Firm location | Tempe, AZ |
| Affected scope | 625 units |
| Distribution | Worldwide - U.S. Nationwide distribution in the states of OH, TX, and WV. The countries of Belgium, Canada, France, Italy, and United Kingdom. |
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-3062-2024) 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? ▼
Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. Please refer to the applicable catheter Instructions for Use for directions on the use of these accessories.. Recalled by Bard Peripheral Vascular Inc. Units affected: 625 units.
Why was this product recalled? ▼
Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the distal end of the hoop. Injury could occur if the user attempts to insert the proximal end into the patient.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2024. Severity: Moderate. Recall number: Z-3062-2024.
Where was the recalled product distributed? ▼
Distribution: Worldwide - U.S. Nationwide distribution in the states of OH, TX, and WV. The countries of Belgium, Canada, France, Italy, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3062-2024) 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 18, 2024. 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.