Z-2446-2014Class I
CENTRAL LINE FULL BODY DRAPE CUSTOMED CONTENTS: (1) WRAPPER 30" X 30" (2) MASK SURGICAL W/ VISOR ANTI-FOG...
Customed, Inc / initiated 2014-05-20 / Terminated / root cause: packaging
Customed, Inc began a recall of CENTRAL LINE FULL BODY DRAPE CUSTOMED CONTENTS: (1) WRAPPER 30" X 30" (2) MASK SURGICAL W/ VISOR ANTI-FOG 160mm Hg (2) CAP NURSE 21" GREEN BOUFFANT (2) TOWELS... 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-2446-2014
- Classification
- Class I
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Customed, Inc
- Product
- CENTRAL LINE FULL BODY DRAPE CUSTOMED CONTENTS: (1) WRAPPER 30" X 30" (2) MASK SURGICAL W/ VISOR ANTI-FOG 160mm Hg (2) CAP NURSE 21" GREEN BOUFFANT (2) TOWELS ABSORBENT 15" X 20" (2) GOWN LARGE STANDARD SMS VELCRO/NECK (1) DRAPE SHEET 41" X 58" SMS (1) DRAPE BRACHIAL ANGlO 44" X 31" REINFORCED 3" ADHESIVE CIRCULAR FENESTRATION 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
- 8 lots/1232 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 900-2262,8 lots 112041231 113036345 113047112 113078310 113088797 140111207 140211823 140312128
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.