Drug recall
TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. Product…
FDA recall event 73318 · Class II · Applied Medical Technology Inc
Key facts
| Event ID | 73318 |
|---|---|
| Recall numbers | Z-1608-2016, Z-1609-2016, Z-1610-2016, Z-1611-2016 |
| Recalling firm | Applied Medical Technology Inc |
| Product type | Devices |
| Products | TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. Product Usage: Indicated to aid in tissue retraction during a surgical procedure., TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure., Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure., Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize Product Usage: Indicated to aid in tissue… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The firm received a complaint of an open pouch which breaches the sterilization validation. |
| Initiation date | Feb 17, 2016 |
| Report date | May 11, 2016 |
| Termination date | Oct 27, 2016 |
| City | Brecksville |
| State | OH |
| Country | United States |
| FEI number | 1526012 |
At a glance
- 1–9 Products in this recall
- 1–9 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: