Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported June 16, 2021
DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the a…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Avid Medical, Inc. recalled DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03. - a critical-severity action.
DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03. was recalled by Avid Medical, Inc. in June 16, 2021. Reason: Medical convenience kits are being recalled due to a potential breach in the package integrity of a component…. Check the official notice for the remedy. Verify recall #Z-1787-2021 with the FDA Devices before acting.
The recall
Avid Medical, Inc. issued this critical-severity FDA Devices recall-Medical convenience kits are being recalled due to a potential breach in the package integrity of a component….
- Critical
- severity level
- Class I
- classification
- June 16, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1787-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1787-2021) was formally reported on June 16, 2021, with the manufacturer initiating the action on April 9, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. Avid Medical, Inc. is listed as the recalling firm, operating out of Toano, VA. Federal records list the affected scope as 560 kits.
The documented reason for this recall is: Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicilli… Distribution data in the federal record shows the product reached: Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
560 kits
Related Recalls
6
3 from same agency
Product description
DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.
Reason for recall
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1787-2021 |
| Date reported | June 16, 2021 |
| Date initiated | April 9, 2021 |
| Recalling firm | Avid Medical, Inc. |
| Firm location | Toano, VA |
| Affected scope | 560 kits |
| Distribution | Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN |
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-1787-2021) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.. Recalled by Avid Medical, Inc.. Units affected: 560 kits.
Why was this product recalled? ▼
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 16, 2021. Severity: Critical. Recall number: Z-1787-2021.
Where was the recalled product distributed? ▼
Distribution: Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1787-2021) 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 June 16, 2021. 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.