DeRoyal Lap Appy TraceCart, REF53-1776, Rx only, non-sterile. (custom surgical kit)
FDA device recall Z-0197-2009 · posted 2008-11-07 · Terminated
Recall details
- Recalling firm
- DeRoyal Industries Inc
- Reason for recall
- Surgical kits contained a recalled Endopath ETX 35 mm Endoscopic Linear Cutter White Reload/Cartridges.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KDD
- Quantity affected
- 4 kits
- Distribution
- LA & KY
- Date initiated
- 2008-10-01
- Date posted
- 2008-11-07
- Date terminated
- 2009-12-02
- Location
- Powell, TN
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