Recall Z-0355-2024 ยท FPA Set, Administration, Intravascular
B. Braun Medical, Inc.
Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; 362033 UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; 362034 Priming volume: 19mL, length: 120in, SafeLine; 362035 INFUSOMAT SPACE PUMP IV SET; 362043 Priming volume: 39mL, length: 120in, SafeLine; 362050 1
| Date | Dec 1, 2023 (initiated Nov 1, 2023) |
| Status | Open, Classified |
| Reason | In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medication administration may result in serious injury to patients which may be life-threatening (e.g. interruption of a vasopressor to a hemodynamically unstable patient) or may lead to death. |
| Root cause | Process control |
| Action | On November 1, 2023, the firm notified customers via URGENT MEDICAL DEVICE CORRECTION letters. Customers were informed that administration sets with lot number 0061902124 and higher were manufactured with revised specifications which should reduce the potential for false air-in-line alarms. After November 30, 2023, all lots distributed by BBMI will have been manufactured with these revised specifications. The firm provided interim measures for users to apply for affected product. For example, users should not use tubing with noticeably smaller outer diameter or which needs to be stretched to |
| Quantity | 33,820,976 units |
| Distribution | Distribution US nationwide, Canada and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142036 | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS B.Braun Medical, Inc., Aug 25, 2014 |