Z-0925-2022Class II

Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV...

Name: Z-0925-2022 Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV...
Creator: Abbott Vascular
Published: 2022-03-11
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2022-03-11 / Open, Classified

FDA source

Abbott Vascular began a recall of 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) on 2022-03-11. FDA classified it as Class II and gives the reason as "Due to an increase in complaint trend for leaks and intermittent/loose connections". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0925-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-11
Posted: 2022-04-13
Recalling firm: Abbott Vascular
Product: 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)
Product code: MAV Syringe, Balloon Inflation
Reason for recall: Due to an increase in complaint trend for leaks and intermittent/loose connections.
FDA root cause: Component change control
Action: On 03/11/2022, the firm sent an "URGENT FIELD SAFETY NOTICE/DEVICE RECALL" Letter via visit, email or mail, to customers informing them that specific lots of 20/30 INDEFLATOR, INDEFLATOR Plus 30 and associated Priority Packs my exhibit leaks and/or a loose connection at the rotating luer assembly or stopcock connection, which could lead to air ingress under vacuum. Customers are instructed to: 1)Immediately stop using the devices from the affected lots 2) Review their inventory, complete and return the provided Effectiveness Check Form 3) Return all unused affected devices to the Recalling Firm 4) Share the Recall Notification with relevant personnel in their organization 5) if the affected products have been further distributed/transferred, notify those customers 6) Report any occurrence of product performance issues or patient adverse events to the Recalling Firm at 800-227-9902 The Recalling Firm: -Has immediately stop shipping devices from affected lots -Conducting an investigation to determine/confirm that there are not other affected products or lots in distribution -Implementing appropriate corrective actions to ensure product performance -Will work to replace inventory when available For questions or assistance contact the local representative or customer service department at 800-227-9902
Quantity in commerce: 7 lots
Distribution: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0925-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0921-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-20	2022-04-13
Z-0922-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-20	2022-04-13
Z-0923-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-20	2022-04-13
Z-0924-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-20	2022-04-13
Z-0925-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-20	2022-04-13

Product code MAV

K962495Class IIIndeflator Plus 30/Plus 30 Priority Pack9with The.096 Or.115 Rotating Hemostatic Valve)Advanced Cardiovascular Systems, Inc. / cleared 1996-09-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)