Recall Z-0673-2010 ยท FPA Set, Administration, Intravascular
B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, 2 Safesite Inj sites, 0.2um Filter, Pressure limited check valve 122 in NF3169F
| Date | Jan 26, 2010 (initiated Nov 24, 2009) |
| Status | Terminated |
| Reason | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the set to be used. This requires a new set to be obtained, thus creating a potential for delay in therapy. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued a Product Removal Notice via US Postal Service Certified Mail with registered return receipt or FedEx to all customers and distributors in receipt of the affected product. The notices were sent 11/30/09 and 12/1/09. Direct customers also received letters addressed to Material Management that informed them of the recall and provided instruction for disposition of affected product in their inventory. Distributors received the direct customer recall letter along with a cover letter outlining their responsibilities to execute the recall and notify their customers. Qu |
| Quantity | 6144 units |
| Distribution | The products were shipped to distributors and medical facilities nationwide. The product was also shipped to Afghanistan, Canada and LU. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942988 | FILTERED EXTENSION SETS B. Braun of America, Inc., Jul 14, 1995 |