Recall Z-0925-2022 ยท MAV Syringe, Balloon Inflation
Abbott Vascular
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)
| Date | Mar 11, 2022 |
| Status | Open, Classified |
| 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 Fi |
| Quantity | 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, Austral |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962495 | INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE) Advanced Cardiovascular Systems, Inc., Sep 12, 1996 |