CLASS II Device recall · Reported 7 Jul 2021 · FDA Enforcement Report
PowerPICC Catheter Single-Lumen recalled by Bard Access Systems
Bard Access Systems is recalling PowerPICC Catheter Single-Lumen with Guidewire Instructions For Use: PowerPicc, distributed in 10 states. The recall was initiated on 19 May 2021 and the FDA has classified it as Class II.
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-1991-2021
- FDA event ID
- 88048
- Recalling firm
- Bard Access Systems, Salt Lake City, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 May 2021
- FDA classified
- 30 Jun 2021
- Reported
- 7 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 19 May 2021 | Recall initiated by company | |
| 30 Jun 2021 | Classified by FDA | +42 days |
| 7 Jul 2021 | 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
Catheter kits contained the incorrect micro-introducers.
Product as listed by the FDA
5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer
Where it was distributed
U.S.: CT, GA, MA, MI, MT, NJ, NV, NY, VA, and WI. O.U.S.: None
ConnecticutGeorgiaMassachusettsMichiganMontanaNew JerseyNevadaNew YorkVirginiaWisconsin
Questions about this recall
Why was it recalled?
Catheter kits contained the incorrect micro-introducers.
Which lots are affected?
Catalog Number: 3175155 UDI Code: (01)00801741027680 Lot Number: REEU0201
Where was it sold?
U.S.: CT, GA, MA, MI, MT, NJ, NV, NY, VA, and WI. O.U.S.: None
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 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 | DuoGlide Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |
| Device | CLASS I | Power-Trialysis Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |
| 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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