Z-2548-2015Class II
ANGIODRAPE PK 4/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 ANGIODRAPE PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc 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-2548-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Customed, Inc
- Product
- ANGIODRAPE PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Product code
- OEQ Angiography/Angioplasty 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
- 192 packs
- Distribution
- Distributed Only in Puerto Rico.
- Product codes and lots
- Catalog number: 900002 Lots: 140714427 exp. 7/30/2017 141014965 exp. 7/30/2017 150116709 exp. 1/31/2016 150318103 exp. 3/31/2016 150418510 exp. 4/30/2016 150519016 exp. 5/31/2016
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.