Adult Metriset w/Cassette 2 inj sites, LL 120 in. Item/Catalog number 375043. The product is shipped 20 units per carton
FDA device recall Z-2408-2008 · posted 2008-09-23 · Terminated
Recall details
- Recalling firm
- B. Braun Medical, Inc.
- Reason for recall
- incorrect burette was packaged with the product
- Action taken
- The firm issued a Product Removal Notice dated 6/20/08 via USPS Certified Mail with registered receipt mail to all customers in receipt of affected product. The notice informs customers of the problem, to cease use and distribution immediately, and to return the product. Contact B. Braun Medical at 1-800-227-2862 for assistance.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 280 units
- Distribution
- Nationwide.
- Date initiated
- 2008-06-30
- Date posted
- 2008-09-23
- Date terminated
- 2009-05-05
- Location
- Allentown, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FILTERED EXTENSION SETS (K942988) | B. Braun of America, Inc. | 1995-07-14 |
| MODIFICATION TO IV SPIKE (K921860) | Mcgaw, Inc. | 1992-07-30 |
| VOLUMETRIC INFUSION PUMP (K904518) | Kendall Mcgaw Laboratories, Inc. | 1990-10-17 |