FDA Medical Device Recalls (openFDA)
Abbott Vascular: 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL2122270-02 (2019-03-01)
- Recall number
- Z-0922-2022
- Recalling firm
- Abbott Vascular
- Product
- 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL2122270-02 (2019-03-01)
- Status
- Open, Classified
- Initiated
- 2022-03-11
- Posted
- not on file
- Terminated
- not on file
- Reason
- Due to an increase in complaint trend for leaks and intermittent/loose connections.
- 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
- 23 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
- Lot, serial or model codes
- Part Numbers: 1000186 Device Identifier-GTIN: 08717648013614 Lot Number: 60317536 60320079 60325409 60317537 60320909 60326623 60317542 60320910 60329936 60318666 60320911 60334116; Part Numbers: 1000186-115 Device Identifier-GTIN: 08717648015274 Lot Number: 60311340 60318662 60329334 60311346 60318663 60334117 60317538 60318664 60334737 60318661 60318665
- 510(k) numbers
- ["K961471"]
- PMA numbers
- not on file
- Product code
- MAV
- Firm FEI
- 2024168
- Firm city
- Temecula
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28