Drug recall
seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier…
FDA recall event 62127 · Class II · Genzyme Corporation
Key facts
| Event ID | 62127 |
|---|---|
| Recall numbers | Z-1855-2012, Z-1856-2012 |
| Recalling firm | Genzyme Corporation |
| Product type | Devices |
| Products | seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct…, seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Sterility of product may be compromised due to packaging defect |
| Initiation date | Jun 13, 2012 |
| Report date | Jun 27, 2012 |
| Termination date | Jul 24, 2013 |
| City | Framingham |
| State | MA |
| Country | United States |
| FEI number | 1220423 |
At a glance
- 1–9 Products in this recall
- 10–99 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: