INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)
- Company
- Abbott Vascular
- Recall Initiated
- March 11, 2022
- Recall Number
- Z-0924-2022
- Quantity
- 6 lots
- Firm Location
- Temecula, CA
Reason for Recall
Due to an increase in complaint trend for leaks and intermittent/loose connections.
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 / Code Info
Part Numbers: 1000183 Device Identifier-GTIN: 08717648013584 Lot Numbers: 60316775 60322179 60328352 60322176 60326322 60337153
Root Cause
Component change control
Action Taken
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