Z-2305-2014Class I
Customed Major Laparotomy Pack , convenience pack include multiple components: Mayo stand cover, absorbent...
Customed, Inc / initiated 2014-05-20 / Terminated / root cause: packaging
Customed, Inc began a recall of Customed Major Laparotomy Pack , convenience pack include multiple components: Mayo stand cover, absorbent towel, bag suture, drape, suction tube, lite glove... on . FDA classified it as Class I and gives the reason as "Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination...". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-2305-2014
- Classification
- Class I
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Customed, Inc
- Product
- Customed Major Laparotomy Pack , convenience pack include multiple components: Mayo stand cover, absorbent towel, bag suture, drape, suction tube, lite glove, gauze/sponges, drape, surgical blades, utility bowls, towels, tube suction, cautery tip, gown, and labels. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
- Product code
- FHI Ring, Laparotomy
- Reason for recall
- Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
- Root cause tag
- packaging
- FDA root cause
- Package design/selection
- Action
- Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit. Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540
- Quantity in commerce
- 34 lots, 5556 units (multiple units per lot)
- Distribution
- Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
- Product codes and lots
- Product code 900-036, 34 lots: 111113166 111123284 112010009 112010241 112020297 112030608 112041067 112051663 112062306 112062580 112072761 112093837 112114906 113015423 113025923 113026201 113036746 113057376 113057765 113068023 113068137 113078565 113089178 113099560 131110082 131110396 131110576 131210954 140111448 140211910 140312429 140412881 140513056 140513343
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2302-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2303-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2304-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2305-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2306-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2307-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2308-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2309-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2310-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2311-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2312-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2313-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2314-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2315-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2316-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2317-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2318-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2319-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2320-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2321-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2322-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2323-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2324-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2325-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2326-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2327-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2328-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2329-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2330-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2331-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2332-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2333-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2334-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2335-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2336-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2337-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2338-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2339-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2340-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2341-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2342-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2343-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2344-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2345-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2346-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2347-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2348-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2349-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2350-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2351-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2352-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2353-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2354-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2355-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2356-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2357-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2358-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2359-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2360-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2361-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2362-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2363-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2364-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2365-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2366-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2367-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2368-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2369-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2370-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2371-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2372-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2373-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2374-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2375-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2376-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2377-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2378-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2379-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2380-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2381-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2382-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2383-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2384-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2385-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2386-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2387-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2388-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2389-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2390-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2391-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2392-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2393-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2394-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2395-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2396-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2397-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2398-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2399-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2400-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2401-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2402-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2403-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2404-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2405-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2406-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2407-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2408-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2409-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2410-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2411-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2412-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2413-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2414-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2415-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2416-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2417-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2418-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2419-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2420-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2421-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2422-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2423-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2424-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2425-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2426-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2427-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2428-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2429-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2430-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2431-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2432-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2433-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2434-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2435-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2436-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2437-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2438-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2439-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2440-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2441-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2442-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2443-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2444-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2445-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2446-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2447-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2448-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2449-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2450-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2451-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2452-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2453-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2454-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2455-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2456-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2457-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2458-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2459-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2460-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2461-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2462-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2463-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2464-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2465-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2466-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2467-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2468-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2469-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2470-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2471-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2472-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2473-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2474-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2475-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2476-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2477-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2478-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2479-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2480-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2481-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2482-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2483-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2484-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2485-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2486-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2487-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2488-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2489-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2490-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2491-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2492-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2493-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2494-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2495-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2496-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2497-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2498-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2499-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2500-2014 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-2501-2014 | Class I | 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.