PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended fo
FDA device recall Z-1560-2015 · posted 2015-04-30 · Terminated
Recall details
- Recalling firm
- Bard Access Systems
- 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.
- Action taken
- The firm, Bard, sent an "URGENT: Notification-Potential Incorrect Infusion IFU Label for PowerLoc MAX Safety Winged Infusion Set (SWIS)" letter dated March 25, 2015 to its customers. The letter described the product, problem and actions taken. The firm has corrected the cause of the issue and all future lots will be manufactured with the correct maximum flow rate of 2mL/second. Customers may return for a replacement or keep items. Please direct any return requests and questions to our coordinator at 801-522-5640.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 700 units
- Distribution
- US Distribution to states of: GA and MN.
- Date initiated
- 2015-03-13
- Date posted
- 2015-04-30
- Date terminated
- 2015-06-24
- Location
- Salt Lake City, UT
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SAFESTEP MAX POWER-INJECTABLE INFUSION SET (K073050) | Specialized Health Products International, Inc. | 2008-01-25 |