EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml; 1.0 mg Ethanol in 1 ml, 10 ampules; Item number 68991/95; in v
FDA device recall Z-1607-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- EMD Chemicals Inc
- Reason for recall
- Incorrect concentration: 2 ampules measuring 2.0 mg/ml were found in a lot of 20 ampules of 1.0 mg/ml Ethanol Standard.
- Action taken
- VWR International and Thermo Fisher Scientific were notified of the recall by e-mail on 3/27/08 and asked to provide end user lists so that recall letters could be sent to each customer. Customers were sent a letter commencing April 3, 2008, by first class mail.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DNN
- Quantity affected
- 99 cases (10 ampules per case)
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-03-27
- Date posted
- 2008-09-16
- Date terminated
- 2008-09-22
- Location
- Gibbstown, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (K990516) | Emd Chemicals, Inc. | 1999-03-31 |