CLASS II Device recall · Reported 6 Mar 2019 · FDA Enforcement Report
Plus 30 Priority Pack Accessory Kit recalled by Abbott Vascular
Abbott Vascular is recalling Plus 30 Priority Pack Accessory Kit, distributed nationwide in the US. The recall was initiated on 3 Jul 2018 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-0960-2019
- FDA event ID
- 82015
- Recalling firm
- Abbott Vascular, Temecula, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Jul 2018
- FDA classified
- 26 Feb 2019
- Reported
- 6 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 3 Jul 2018 | Recall initiated by company | |
| 26 Feb 2019 | Classified by FDA | +238 days |
| 6 Mar 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect expiration being entered for one lot.
Product as listed by the FDA
PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).
Where it was distributed
US Nationwide Distribution - NC and NY
Questions about this recall
Is Plus 30 Priority Pack Accessory Kit recalled?
Yes. Abbott Vascular recalled Plus 30 Priority Pack Accessory Kit on 3 Jul 2018. The recall is Class II and its status is Terminated. Recall number Z-0960-2019.
Why was it recalled?
Incorrect expiration being entered for one lot.
Which lots are affected?
Device Identifier #: 08717648 01360 7 Part Number: 1000185 Lot number: 60047593
Where was it sold?
US Nationwide Distribution - NC and NY
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 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 Abbott Vascular
All 42| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 20/30 Priority Pack Kit/.115 RHV recalled by Abbott Vascular | Abbott Vascular | Lead & Heavy Metals | 40 states |
| Device | CLASS II | 20/30 Indeflator, REF: 1000184, for use during cardiovascular recalled | Abbott Vascular | Lead & Heavy Metals | 40 states |
| Device | CLASS II | 20/30 Priority Pack Accessory Kit/.096 RHV recalled by Abbott Vascular | Abbott Vascular | Lead & Heavy Metals | 40 states |
| Device | CLASS II | 20/30 Priority Pack Accessory Kit w/Copilot recalled by Abbott Vascular | Abbott Vascular | Lead & Heavy Metals | 40 states |
| Device | CLASS II | Product/Part: MitraClip G4 CDS NT Repair-mr recalled by Abbott Vascular | Abbott Vascular | Lead & Heavy Metals | 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 |