Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported November 11, 2015
Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
C.r. Bard, Inc. recalled Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 3… - a low-severity action.
Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 3… was recalled by C.r. Bard, Inc. in November 11, 2015. Reason: Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 F…. Check the official notice for the remedy. Verify recall #Z-0198-2016 with the FDA Devices before acting.
The recall
C.r. Bard, Inc. issued this low-severity FDA Devices recall-Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 F….
- Low
- severity level
- 4K units
- affected scope
- Class III
- classification
- November 11, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0198-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0198-2016) was formally reported on November 11, 2015, with the manufacturer initiating the action on October 2, 2015. It is classified under Low severity (Class III), with a current status of Terminated. C.r. Bard, Inc. is listed as the recalling firm, operating out of Covington, GA. Federal records list the affected scope as 4,170 each.
The documented reason for this recall is: Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French. Distribution data in the federal record shows the product reached: Nationwide Distribution including CA, FL, IL, MO, NJ, OR, PA, TX & WA.. 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
4,170 each
Related Recalls
6
3 from same agency
Product description
Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
Reason for recall
Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0198-2016 |
| Date reported | November 11, 2015 |
| Date initiated | October 2, 2015 |
| Recalling firm | C.r. Bard, Inc. |
| Firm location | Covington, GA |
| Affected scope | 4,170 each |
| Distribution | Nationwide Distribution including CA, FL, IL, MO, NJ, OR, PA, TX & WA. |
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-0198-2016) 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? ▼
Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units. Recalled by C.r. Bard, Inc.. Units affected: 4,170 each.
Why was this product recalled? ▼
Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 11, 2015. Severity: Low. Recall number: Z-0198-2016.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including CA, FL, IL, MO, NJ, OR, PA, TX & WA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0198-2016) 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 November 11, 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.