Z-2552-2015Class II
LAPAROSCOPY PK 3/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 LAPAROSCOPY PK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds... 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-2552-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Customed, Inc
- Product
- LAPAROSCOPY PK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
- Product code
- FDE Laparoscopy Kit
- 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
- 339 packs
- Distribution
- Distributed Only in Puerto Rico.
- Product codes and lots
- Catalog number:900028 Lots: 141015610 exp. 10/31/15 140814877 exp. 10/31/15 140814877 exp. 10/31/15 140814877 exp. 10/31/15 150116717 exp. 1/31/16 150116716 exp. 10/31/15 150116715 exp. 10/31/15 150116719 exp. 1/31/16 150116714 exp. 10/31/15 150116718 exp. 1/31/16
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.