Z-2319-2014Class I
ANGIODRAPE PACK - - (1) GUIDEWIRE 0.035" X 150cm (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK UF (2) Pr. SURGICAL...
Customed, Inc / initiated 2014-05-20 / Terminated / root cause: packaging
Customed, Inc began a recall of ANGIODRAPE PACK - - (1) GUIDEWIRE 0.035" X 150cm (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK UF (2) Pr. SURGICAL GLOVES #8 (2) GOWN STANDARD LARGE SMS VELCRO NECK... 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-2319-2014
- Classification
- Class I
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Customed, Inc
- Product
- ANGIODRAPE PACK - - (1) GUIDEWIRE 0.035" X 150cm (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK UF (2) Pr. SURGICAL GLOVES #8 (2) GOWN STANDARD LARGE SMS VELCRO NECK (2) NEEDLE HYPODERMIC 21G X 1 W' UF (1) TABLE COVER 44" X 90" (3) CLOTH HUCK TOWELS BLUE (2) UTILITY BOWL 16oz L/F (1) SOLUTION SURGICAL DURAPREP 26ML UF (3) DRAPE UTILITY WITH TAPE UF (3) TOWEL CLAMP (2) TOWELS ABSORBENT 15" X 20" UF (1) NEEDLE 18G X 2% AMC/4 (1) FEMORAL ANGlO DRAPE WITH POUCH UF (1) BAND BAG RUBBAND & TAPE UF (1) CUP DENTURE WITH LID (30) GAUZE SPONGE 4" X 4" 12PL Y (2) TIP ASBORBENT APPLICATOR STICK SPONGE (1) SCALPEL WITH HANDLE #11 (1) STOPCOCK 3 WAY (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK L/F (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK L/F 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
- 5 lots; 180 units (multiple lots per unit)
- 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 900-366, 5 lots: 113026100 113057477 113078475 113088811 113109832
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.