PowerLoc MAX Safety Winged Infusion Set — Class II medical device recall Z-1560-2015
Terminated recall by Bard Access Systems, reported 2015-05-06, distributed in GA, MN. Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum Flow rate labe
| Recall number | Z-1560-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Access Systems, Salt Lake City, UT, United States |
| Recall initiated | 2015-03-13 |
| Classified | 2015-04-30 |
| Reported by FDA | 2015-05-06 |
| Terminated | 2015-06-24 |
| Distributed | GA, MN |
| Quantity | 700 units |
| Reason classes | labeling |
| Lot numbers | D430107 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1560-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.