FDA Enforcement
Class III
Terminated
EDI BZO Uncut Sheet - Cup*, Item No. 160170
Recall: Z-0501-2016
·
Reported December 30, 2015
Enforcement
- Recall Number
- Z-0501-2016
- Event ID
- 72651
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ameditech Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 30, 2015
- Initiation Date
- November 16, 2015
- Classification Date
- December 24, 2015
- Termination Date
- November 9, 2016
- Address
- 9940 Mesa Rim Rd, N/A, San Diego, CA, 92121-2910, United States
Description
EDI BZO Uncut Sheet - Cup*, Item No. 160170
Reason
Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.
Code Info
141260 141294 141909 141925 142074 142243 142428 142614 142712 142911 144555 151925 152003 152223 152498 152723 152897 153311 153559 153818 154184 152103
Distribution
Nationwide Distribution.
Quantity
45,584 kits