CLASS III Device recall · Reported 15 Jul 2015 · FDA Enforcement Report
PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray recalled
Bard Access Systems is recalling PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single-Lumen), distributed nationwide in the US. The recall was initiated on 27 May 2015 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2050-2015
- FDA event ID
- 71420
- Recalling firm
- Bard Access Systems, Salt Lake City, UT
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 May 2015
- FDA classified
- 8 Jul 2015
- Reported
- 15 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 27 May 2015 | Recall initiated by company | |
| 8 Jul 2015 | Classified by FDA | +42 days |
| 15 Jul 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.
Product as listed by the FDA
PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single-Lumen) (Sherlock) The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
Where it was distributed
Nationwide Distribution
Questions about this recall
Is PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single-Lumen) recalled?
Yes. Bard Access Systems recalled PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single-Lumen) on 27 May 2015. The recall is Class III and its status is Terminated. Recall number Z-2050-2015.
Why was it recalled?
Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.
Which lots are affected?
Lot No: REYK1761, Item No. 9194108D
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Bard Access Systems
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|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | 5605150 Power-Trialysis Short-Term Straight Dialysis recalled | Bard Access Systems | Other | Nationwide |
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| Device | CLASS II | 4380 Economy Soft Tissue Biopsy Tray recalled by Bard Access Systems | Bard Access Systems | Other | Nationwide |
| Device | CLASS II | CK000980A PowerMidline Catheter Dual-Lumen recalled | Bard Access Systems | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |