Recall Z-1129-2007 ยท FPA Set, Administration, Intravascular
Curlin Medical Llc
Curlin Medical Administration Sets: Model Numbers 340-4111, IV Administration Sets.
| Date | Aug 7, 2007 (initiated Feb 9, 2007) |
| Status | Terminated |
| Reason | The Administration Sets may leak at the reservior bag. |
| Root cause | Other |
| Action | A Field Correction Advisory (Recall Letter) was issued on February 9, 2007 to the firm's one US Customer (distributor): B. Braun Medical Inc. recalling Curlin Medical, Inc. Administration Sets 340-4111- Lot # D628223 and D627616 because the affected lots do not meet acceptable performance levels. A second Field Correction Advisory (Recall Letter) was issued on March 15, 2007 to B. Braun Medical Inc. recalling Curlin Medical, Inc. Administration Sets: 340-4111- Lot # D628223, D6276l6 ,D620544, D630503; 340-4127- Lot# D620104; 340-4119- Lot# D623716 because the affected lots do not meet accepta |
| Quantity | 25, 280 |
| Distribution | One US Customer (distributor): B. Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981816 | CUE AMBULATORY VOLUMETRIC INFUSION PUMP Becton Dickinson Curlin, LLC, Dec 4, 1998 |