Recalls / —
—#73795
Product
DeRoyal Lap Chole Tray, REF 89-4823.06, Rx, Sterile EO. (custom surgical kit)
- FDA product code
- KDD — Kit, Surgical Instrument, Disposable
- Device class
- Class 1
- Medical specialty
- General, Plastic Surgery
- Affected lot / code info
- Lot number 13063705
Why it was recalled
Surgical kits contained a recalled Endopath ETX 35 mm Endoscopic Linear Cutter White Reload/Cartridges.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
The firm sent out recall notices to their sales representatives, the distributors, and the hospitals addressed to the Recall Coordinator/OR Supervisor on 10/2/08. These notices stated that the recalling firm's sales representatives would perform the field correction in lieu of returning the kits. Contact DeRoyal Industries, Inc. at 1-865-362-6157 for assistance.
Recalling firm
- Firm
- DeRoyal Industries Inc
- Address
- 200 Debusk Ln, Powell, Tennessee 37849-4703
Distribution
- Distribution pattern
- LA & KY
Timeline
- Recall initiated
- 2008-10-01
- Posted by FDA
- 2008-11-07
- Terminated
- 2009-12-02
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #73795. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.