Z-2492-2014Class I
Breast Implant Pack, Code 900-2660, contains: (1) DRAPE ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD XLGE SET...
Customed, Inc / initiated 2014-05-20 / Terminated / root cause: packaging
Customed, Inc began a recall of Breast Implant Pack, Code 900-2660, contains: (1) DRAPE ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD XLGE SET IN SLEEVE (3) TOWELS ABSORBENT 15 X 20 (1) MAYO... 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-2492-2014
- Classification
- Class I
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Customed, Inc
- Product
- Breast Implant Pack, Code 900-2660, contains: (1) DRAPE ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD XLGE SET IN SLEEVE (3) TOWELS ABSORBENT 15 X 20 (1) MAYO STAND COVER REINFORCED (2) TABLE COVER REINFORCED 50 X 90 (1) SUTURE BAG FLORAL (1) TUBE SUCTION CONNECT Y (6) TOWEL CLOTH HUCK BLUE (4) PAD ABDOMINAL 8 X 7.5 (2) LITE GLOVES (1) CAUTERY TIP POLISHER LIF (1) BLADE SURGICAL CARBON STEEL 15 (1) YANKAUER SUCTION TUBE W/0 VENT (1 0) LAP SPONGE PREWASH 18 X 18 XRD (1) CAUTERY PENCIL ROCKER SWITCH W/HOLSTER (1) UNDERPAD 23 X 36 Product Usage: 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
- 2 lots/ 54 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
- Code 900-2660, 2 lots: 112062218 112093621
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.