Z-2717-2015Class II
C-SECTION PK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as...
Customed, Inc / initiated 2015-07-10 / Terminated / root cause: packaging
Customed, Inc began a recall of C-SECTION PK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate on . FDA classified it as Class II and gives the reason as "Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-2717-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Customed, Inc
- Product
- C-SECTION PK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
- Product code
- OHM Cesarean Section Tray
- Reason for recall
- Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- Root cause tag
- packaging
- FDA root cause
- Packaging
- Action
- Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.
- Quantity in commerce
- 92
- Distribution
- Distributed Only in Puerto Rico.
- Product codes and lots
- Code: 900998 Lots: 141015749 exp. 10/31/15 141015749 exp. 10/31/15 140915186 exp. 11/30/15 150116835 exp. 3/31/16 150317856 exp. 3/31/16 150317857 exp. 3/31/16 150518853 exp. 5/31/16
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2548-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2549-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2550-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2551-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2552-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2553-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2554-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2555-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2556-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2557-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2558-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2559-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2560-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2561-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2562-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2563-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2564-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2565-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2566-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2567-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2568-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2569-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2570-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2571-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2572-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2573-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2574-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2575-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2576-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2577-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2578-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2579-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2580-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2581-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2582-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2583-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2584-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2585-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2586-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2587-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2588-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2589-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2590-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2591-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2592-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2593-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2594-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2595-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2596-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2597-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2598-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2599-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2600-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2601-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2602-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2603-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2604-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2605-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2606-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2607-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2608-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2609-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2610-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2611-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2612-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2613-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2614-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2615-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2616-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2617-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2618-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2619-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2620-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2621-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2622-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2623-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2624-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2625-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2626-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2627-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2628-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2629-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2630-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2631-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2632-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2633-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2634-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2635-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2636-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2637-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2638-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2639-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2640-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2641-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2642-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2643-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2644-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2645-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2646-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2647-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2648-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2649-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2650-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2651-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2652-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2653-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2654-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2655-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2656-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2657-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2658-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2659-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2660-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2661-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2662-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2663-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2664-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2665-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2666-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2667-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2668-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2669-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2670-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2671-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2672-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2673-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2674-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2675-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2676-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2677-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2678-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2679-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2680-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2681-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2682-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2683-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2684-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2685-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2686-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2687-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2688-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2689-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2690-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2691-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2692-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2693-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2694-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2695-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2696-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2697-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2698-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2699-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2700-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2701-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2702-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2703-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2704-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2705-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2706-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2707-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2708-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2709-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2710-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2711-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2712-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2713-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2714-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2715-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2716-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2717-2015 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.