Drug recall
American Surgical Americot Blue 1/2" x 1/2" Ref Number: 20-04S Product Usage: Neurosurgical and…
FDA recall event 73734 · Class II · American Surgical Company
Key facts
| Event ID | 73734 |
|---|---|
| Recall numbers | Z-1721-2016, Z-1722-2016, Z-1723-2016, Z-1724-2016, Z-1725-2016, Z-1726-2016, Z-1727-2016, Z-1728-2016, Z-1729-2016, Z-1730-2016, Z-1731-2016, Z-1732-2016 and 79 more |
| Recalling firm | American Surgical Company |
| Product type | Devices |
| Products | American Surgical Americot Blue 1/2" x 1/2" Ref Number: 20-04S Product Usage: Neurosurgical and Nonneurosurgical Sponges, American Surgical Americot Blue 1/2" x 1.5" Ref Number: 20-06S Product Usage: Neurosurgical and Nonneurosurgical Sponges, American Surgical Americot Blue 1/2" x 1" Ref Number: 20-05S Product Usage: Neurosurgical and Nonneurosurgical Sponges Product Usage: Neurosurgical and Nonneurosurgical Sponges, American Surgical Americot Blue 1/2" x 2" Ref Number: 20-32S Product Usage: Neurosurgical and Nonneurosurgical Sponges, American Surgical Americot Blue 1/2" x 3" Ref Number: 20-07S Product Usage: Neurosurgical and Nonneurosurgical Sponges and 85 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product packaging defective compromising sterility |
| Initiation date | Mar 31, 2016 |
| Report date | Jun 1, 2016 |
| Termination date | Oct 21, 2016 |
| City | Salem |
| State | MA |
| Country | United States |
| FEI number | 3011047247 |
At a glance
- 10–99 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: