CLASS II ONGOING Device recall · Reported 20 Apr 2022 · FDA Enforcement Report
Plus 30 Priority Pack w/.096 RHV recalled by Abbott Vascular
Abbott Vascular is recalling Plus 30 Priority Pack w/.096 RHV, distributed nationwide in the US. The recall was initiated on 11 Mar 2022 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-0925-2022
- FDA event ID
- 89760
- Recalling firm
- Abbott Vascular, Temecula, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Mar 2022
- FDA classified
- 13 Apr 2022
- Reported
- 20 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 11 Mar 2022 | Recall initiated by company | |
| 13 Apr 2022 | Classified by FDA | +33 days |
| 20 Apr 2022 | 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
Due to an increase in complaint trend for leaks and intermittent/loose connections.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (2019-03-01)
Where it was distributed
U.S Nationwide Distribution.: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TN, TX, VA, WA, and WI. O.U.S.: United Arab Emirates, France, Pakistan, Argentina, United Kingdom, Portugal, Australia, Greece, R¿union, Belgium, Guam, Romania, Brazil, Indonesia, Russian Federation, Bahamas, Israel, Saudi Arabia, Canada, India, Singapore, Switzerland, Italy, Slovakia, Chile, Jamaica, Thailand, China, Japan, Taiwan Republic of China, Colombia, Korea (South), Costa Rica, Luxembourg, Uruguay, Czech Republic, Mexico, Vietnam, Germany, Netherlands, South Africa, Dominican Republic, New Zealand, Spain, and Panama
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichigan
Questions about this recall
Why was it recalled?
Due to an increase in complaint trend for leaks and intermittent/loose connections.
Which lots are affected?
Part Numbers: 1000185 Device Identifier-GTIN: 8717648013607 Lot Numbers: 60317532 60323314 60329935 60323313 60326601 Part Numbers: 1000185-115 Device Identifier-GTIN: 08717648015267 Lot Numbers: 60316763 60323315
Where was it sold?
U.S Nationwide Distribution.: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TN, TX, VA, WA, and WI. O.U.S.: United Arab Emirates, France, Pakistan, Argentina, United Kingdom, Portugal, Australia, Greece, R¿union, Belgium, Guam, Romania, Brazil, Indonesia, Russian Federation, Bahamas, Israel, Saudi Arabia, Canada, India, Singapore, Switzerland, Italy, Slovakia, Chile, Jamaica, Thailand, China, Japan, Taiwan Republic of China, Colombia, Korea (South), Costa Rica, Luxembourg, Uruguay, Czech Republic, Mexico, Vietnam, Germany, Netherlands, South Africa, Dominican Republic, New Zealand, Spain, and Panama
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.
Other products in this recall event
4 other products · FDA event 89760| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Indeflator Plus recalled by Abbott Vascular | Abbott Vascular | Packaging Defects | Nationwide | |
| CLASS II | 20/30 Indeflator -REF 1000184 WPL2122268-01 (2019-03-01) recalled | Abbott Vascular | Packaging Defects | Nationwide | |
| CLASS II | 20/30 Priority Pack Accessory Kit/.096 RHV recalled by Abbott Vascular | Abbott Vascular | Packaging Defects | Nationwide | |
| CLASS II | 20/30 Priority Pack w/Copilot recalled by Abbott Vascular | Abbott Vascular | Packaging Defects | Nationwide |
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 | Packaging Defects | 40 states |
| Device | CLASS II | 20/30 Indeflator, REF: 1000184, for use during cardiovascular recalled | Abbott Vascular | Packaging Defects | 40 states |
| Device | CLASS II | 20/30 Priority Pack Accessory Kit/.096 RHV recalled by Abbott Vascular | Abbott Vascular | Packaging Defects | 40 states |
| Device | CLASS II | 20/30 Priority Pack Accessory Kit w/Copilot recalled by Abbott Vascular | Abbott Vascular | Packaging Defects | 40 states |
| Device | CLASS II | Product/Part: MitraClip G4 CDS NT Repair-mr recalled by Abbott Vascular | Abbott Vascular | Device Malfunction | Nationwide |
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