Ethanol Standard, 0.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case. Item
FDA device recall Z-0684-03 · posted 2003-03-26 · Terminated
Recall details
- Recalling firm
- EMD Chemicals Inc
- Reason for recall
- The Ethanol Standard is OOS on the low end. The results were 0.44 mg/mL while the specification is 0.48-0.52 mg/mL.
- Action taken
- All customers were nofitied by phone and letter. The first notification occurred on 12/17/2002 followed with additional notifications on 1/24/2003, 1/28/2003, and 2/4/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- LCH
- Quantity affected
- 139 cases of 10 ampules
- Distribution
- The Ethanol Products were distributed nationwide by the following distributors: VWR International, 1310 Goshen Pkwy, West Chester, PA 19380; Government Scientific, 8460 K-Tyco Road, Vienna, VA 22182;
- Date initiated
- 2002-12-13
- Date posted
- 2003-03-26
- Date terminated
- 2003-05-08
- 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 |