Z-2308-2014Class I
Customed Femoral Pack , convenience pack include multiple components: Syringe 3cc, 5cc, 10cc, 20cc; swabstick...
Customed, Inc / initiated 2014-05-20 / Terminated / root cause: packaging
Customed, Inc began a recall of Customed Femoral Pack , convenience pack include multiple components: Syringe 3cc, 5cc, 10cc, 20cc; swabstick chlorascrub, needles, gauze/sponges, table cover... 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-2308-2014
- Classification
- Class I
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Customed, Inc
- Product
- Customed Femoral Pack , convenience pack include multiple components: Syringe 3cc, 5cc, 10cc, 20cc; swabstick chlorascrub, needles, gauze/sponges, table cover, absrobent towels, halsted Mosquito CVD, gown, bowls, wrapper, scalpel safety, Mosquito forcep, cloth huck, clamp towel, fluorocover, medicine cup, femoral angiodrape, mayo tray, counter & labels. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
- Product code
- LRO General Surgery Tray
- 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
- 14 lots; 855 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 900-164, 14 lots: 110061393 113046935 113047213 113047335 113057700 113068153 113109743 131110191 131110600 140111164 140211648 140311924 140513392 140513453
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.