Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 6, 2015
PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. The PowerLoc MAX SWIS is also indicated for power injection of contrast media into the central venous system only with an implanted port that is also indicated for power injection.
Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum Flow rate label associated to the power injection IFU for the PowerLoc MAX Safety I…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Bard Access Systems recalled PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety … - a moderate-severity action.
PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety … was recalled by Bard Access Systems in May 6, 2015. Reason: Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum Flow rate lab…. Check the official notice for the remedy. Verify recall #Z-1560-2015 with the FDA Devices before acting.
The recall
Bard Access Systems issued this moderate-severity FDA Devices recall-Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum Flow rate lab….
- Moderate
- severity level
- 700 units
- affected scope
- Class II
- classification
- May 6, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1560-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1560-2015) was formally reported on May 6, 2015, with the manufacturer initiating the action on March 13, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Bard Access Systems is listed as the recalling firm, operating out of Salt Lake City, UT. Federal records list the affected scope as 700 units.
The documented reason for this recall is: Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum Flow rate label associated to the power injection IFU for the PowerLoc MAX Safety Infusion Set (SWIS) was attached to the o… Distribution data in the federal record shows the product reached: US Distribution to states of: GA and MN.. 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
700 units
Related Recalls
6
3 from same agency
Product description
PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. The PowerLoc MAX SWIS is also indicated for power injection of contrast media into the central venous system only with an implanted port that is also indicated for power injection.
Reason for recall
Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum Flow rate label associated to the power injection IFU for the PowerLoc MAX Safety Infusion Set (SWIS) was attached to the outside of the unit pouch.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1560-2015 |
| Date reported | May 6, 2015 |
| Date initiated | March 13, 2015 |
| Recalling firm | Bard Access Systems |
| Firm location | Salt Lake City, UT |
| Affected scope | 700 units |
| Distribution | US Distribution to states of: GA and MN. |
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-1560-2015) 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? ▼
PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. The PowerLoc MAX SWIS is also indicated for power injection of contrast media into the central venous system only with an implanted port that is also indicated for power injection.. Recalled by Bard Access Systems. Units affected: 700 units.
Why was this product recalled? ▼
Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum Flow rate label associated to the power injection IFU for the PowerLoc MAX Safety Infusion Set (SWIS) was attached to the outside of the unit pouch.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 6, 2015. Severity: Moderate. Recall number: Z-1560-2015.
Where was the recalled product distributed? ▼
Distribution: US Distribution to states of: GA and MN..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1560-2015) 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.
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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 May 6, 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.