Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
FDA device recall Z-2166-2013 · posted 2013-09-06 · Terminated
Recall details
- Recalling firm
- B. Braun Medical, Inc.
- Reason for recall
- Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375038), and the investigation determined that one of the ULTRASITE injection sites and corresponding low pressure backcheck valve was assembled upside down.
- Action taken
- On August 4, 2013, a letter was sent to direct accounts asking them to check their inventory for the affected product. These customers were also instructed to notify their customers if the product was further distributed and to return all affected product and/or the product removal acknowledgement form.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 900
- Distribution
- Distributed in the states of FL, NY, NJ, and TX.
- Date initiated
- 2013-08-05
- Date posted
- 2013-09-06
- Date terminated
- 2014-09-03
- Location
- Allentown, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| V2 INJECTION SITE (K955585) | B.Braun Medical, Inc. | 1996-05-15 |
| MODIFICATION TO IV SPIKE (K921860) | Mcgaw, Inc. | 1992-07-30 |
| VOLUMETRIC INFUSION PUMP (K904518) | Kendall Mcgaw Laboratories, Inc. | 1990-10-17 |