CLASS II Device recall · Reported 7 Jul 2021 · FDA Enforcement Report
IR PowerPICC Convenience Kit Catheter Dual Lumen recalled
Bard Access Systems is recalling IR PowerPICC Convenience Kit Catheter Dual Lumen with Guidewire Unit Label: PowerPICC, distributed nationwide in the US. 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-1994-2021
- FDA event ID
- 88057
- Recalling firm
- Bard Access Systems, Salt Lake City, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 May 2021
- FDA classified
- 1 Jul 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 | |
| 1 Jul 2021 | Classified by FDA | +43 days |
| 7 Jul 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.
Product as listed by the FDA
5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire Unit Label: PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire
Where it was distributed
U.S. Nationwide distribution in the state of RI.
Questions about this recall
Why was it recalled?
Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire.
Which lots are affected?
Catalog (REF) Number: CK000340B UDI Code: (01)00801741126697 Lot Number: 20BBK658
Where was it sold?
U.S. Nationwide distribution in the state of RI.
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 |
| Device | CLASS II | 1174108 PowerPICC Catheter Single-Lumen recalled by Bard Access Systems | Bard Access Systems | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,212| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Imager II Angiographic Catheters M001314001 Imager recalled | Boston Scientific | Other | Nationwide |
| Device | CLASS II | Olympus EZDilate Endoscopic Balloon Dilator Wired-guided recalled | Olympus Corporation of the Americas | Other | PA |
| Device | CLASS II | Cardioroot Woven Collagen Coated Vascular Graft recalled | SAS Intervascular | Other | Nationwide |
| Device | CLASS II | Automated Impella Controller (AIC) recalled by Abiomed | Abiomed | Potency & Assay | Nationwide |
| Device | CLASS I | DuoGlide Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |