Drug recall
1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429
FDA recall event 84772 · Class II · Ethicon, Inc.
Key facts
| Event ID | 84772 |
|---|---|
| Recall numbers | Z-1334-2020, Z-1335-2020, Z-1336-2020 |
| Recalling firm | Ethicon, Inc. |
| Product type | Devices |
| Products | 1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429, 1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201, 1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The product do not meet certain internal testing specifications. |
| Initiation date | Aug 28, 2019 |
| Report date | Feb 26, 2020 |
| Termination date | Feb 11, 2021 |
| City | Somerville |
| State | NJ |
| Country | United States |
| FEI number | 2210968 |
At a glance
- 1–9 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: