Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 22, 2014
V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STERILE Single Use only Latex Free Rx Only.
A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufactured with an incorrect expiry date on the sterile pouch. The correct expiry dat…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Kci USA, Inc. recalled V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help r… - a moderate-severity action.
V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help r… was recalled by Kci USA, Inc. in October 22, 2014. Reason: A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufactured with …. Check the official notice for the remedy. Verify recall #Z-0070-2015 with the FDA Devices before acting.
The recall
Kci USA, Inc. issued this moderate-severity FDA Devices recall-A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufactured with ….
- Moderate
- severity level
- Class II
- classification
- October 22, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0070-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0070-2015) was formally reported on October 22, 2014, with the manufacturer initiating the action on September 18, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Kci USA, Inc. is listed as the recalling firm, operating out of San Antonio, TX. Federal records list the affected scope as 1090 pouches (109 boxes).
The documented reason for this recall is: A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufactured with an incorrect expiry date on the sterile pouch. The correct expiry date of 2015-11 is on the case label, howev… Distribution data in the federal record shows the product reached: The affected product was distributed to Mexico, Turkey, and United Arab Emirates only. The affected product was not distributed to the US.. 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
1090 pouches (109 boxes)
Related Recalls
6
3 from same agency
Product description
V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STERILE Single Use only Latex Free Rx Only.
Reason for recall
A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufactured with an incorrect expiry date on the sterile pouch. The correct expiry date of 2015-11 is on the case label, however the pouch label identifies the expiry date of 2016-11.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0070-2015 |
| Date reported | October 22, 2014 |
| Date initiated | September 18, 2014 |
| Recalling firm | Kci USA, Inc. |
| Firm location | San Antonio, TX |
| Affected scope | 1090 pouches (109 boxes) |
| Distribution | The affected product was distributed to Mexico, Turkey, and United Arab Emirates only. The affected product was not distributed to the US. |
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-0070-2015) 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? ▼
V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STERILE Single Use only Latex Free Rx Only.. Recalled by Kci USA, Inc.. Units affected: 1090 pouches (109 boxes).
Why was this product recalled? ▼
A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufactured with an incorrect expiry date on the sterile pouch. The correct expiry date of 2015-11 is on the case label, however the pouch label identifies the expiry date of 2016-11.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 22, 2014. Severity: Moderate. Recall number: Z-0070-2015.
Where was the recalled product distributed? ▼
Distribution: The affected product was distributed to Mexico, Turkey, and United Arab Emirates only. The affected product was not distributed to the US..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0070-2015) 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.
Nearby Recalls in This Category
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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 October 22, 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.