Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 27, 2013
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.
The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of the sterility of this access…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medrad Inc recalled MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheteriz… - a moderate-severity action.
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheteriz… was recalled by Medrad Inc in February 27, 2013. Reason: The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath pa…. Check the official notice for the remedy. Verify recall #Z-0870-2013 with the FDA Devices before acting.
The recall
Medrad Inc issued this moderate-severity FDA Devices recall-The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath pa….
- Moderate
- severity level
- 832K units
- affected scope
- Class II
- classification
- February 27, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0870-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0870-2013) was formally reported on February 27, 2013, with the manufacturer initiating the action on November 5, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Medrad Inc is listed as the recalling firm, operating out of Warrendale, PA. Federal records list the affected scope as 832,175, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of the sterility of this accessory. Distribution data in the federal record shows the product reached: Worldwide Distribution including USA nationwide.. 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
832,175
Related Recalls
6
3 from same agency
Product description
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.
Reason for recall
The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of the sterility of this accessory.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0870-2013 |
| Date reported | February 27, 2013 |
| Date initiated | November 5, 2012 |
| Recalling firm | Medrad Inc |
| Firm location | Warrendale, PA |
| Affected scope | 832,175 |
| Distribution | Worldwide Distribution including USA nationwide. |
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-0870-2013) 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? ▼
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.. Recalled by Medrad Inc. Units affected: 832,175.
Why was this product recalled? ▼
The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of the sterility of this accessory.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 27, 2013. Severity: Moderate. Recall number: Z-0870-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution including USA nationwide..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0870-2013) 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 February 27, 2013. 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.