Curlin Medical Administration Sets: Model Numbers 340-4111, IV Administration Sets.
FDA device recall Z-1129-2007 · posted 2007-08-07 · Terminated
Recall details
- Recalling firm
- Curlin Medical Llc
- Reason for recall
- The Administration Sets may leak at the reservior bag.
- Action taken
- 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 acceptable performance levels.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 25, 280
- Distribution
- One US Customer (distributor): B. Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109
- Date initiated
- 2007-02-09
- Date posted
- 2007-08-07
- Date terminated
- 2008-05-28
- Location
- Huntington Beach, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CUE AMBULATORY VOLUMETRIC INFUSION PUMP (K981816) | Becton Dickinson Curlin, LLC | 1998-12-04 |