Recall Z-0321-2018 ยท CAH Filter, Bacterial, Breathing-Circuit
King Systems Corp. dba Ambu, Inc.
UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF4116-6121Z, D466-61Z, DFP170-6121, DF3115-6121Z, DF375-6121Z, DF3115-6121Z, DF3115-6121Z, D360-8031Z, D465-61Z, JD365-6033Z, DF370-6121Z, DF3110-61Z, DF375-17621Z, DF375-6121Z, DF475-17621Z, DF370-6121Z, DF375-6121Z, DF470-6021Z, D366-618Z, D390-60Z, D390-61Z, DP260-61, DF370-6121Z, D3120-6154Z, F95100
| Date | Mar 15, 2017 |
| Status | Terminated |
| Reason | Potential for leak test failures. |
| Root cause | Nonconforming Material/Component |
| Action | On 3/15/2017, the firm issued a letter to its sales force describing its intent to replace product for consignees that complained about leaking. The firm also issued a copy of the manifold IFU that includes the need for a 1/4 turn in the Universal Flex2 Breathing Circuit (with bacterial filter). |
| Quantity | 871,116 units |
| Distribution | Distribution Pattern Distributors in 44 states: Al, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI WY; International Pattern - Canada, China, Chile |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973797 | BREATHING CIRCUIT BACTERIAL FILTER King Systems Corp., Mar 12, 1998 |