Applied Medical 15x100mm Kii Optical Access System, Non-Threaded 6/Box, Model Number: C0R36, Labeled Sterile. Disposable
FDA device recall Z-2226-2009 · posted 2009-09-18 · Terminated
Recall details
- Recalling firm
- Applied Medical Resources Corp
- Reason for recall
- Applied Medical is conducting a coluntary recall of two lot numbers, 1084426 and 1085506, of the 15mm Kii non-threaded optical access system, model C0R36, due to a potential weakness in the cannula tip, possibly resulting in tip breakage.
- Action taken
- Applied Medical Resources Corp. notified Customers via an overnight "Voluntary Recall Notification" Letter dated June 9, 2009. The letter informed customers of the reason for recall and asked that the listed product be returned. The recall letter provided customers with a contact and telephone number for product return questions (1-949-713-8652) and a separate contact for regulatory questions (1-949-713-8369).
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 934 units
- Distribution
- Class II Recall - Worldwide -- United States, Australia, New Zealand, France, Canada, Norway and Great Britain.
- Date initiated
- 2009-06-04
- Date posted
- 2009-09-18
- Date terminated
- 2011-07-14
- Location
- Rancho Santa Margarita, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODULAR TROCAR SYSTEM (K060096) | Applied Medical Resources Corp. | 2006-01-24 |