Z-2348-2014Class I

CARPALTUNNELLARGE - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1)...

Name: Z-2348-2014 CARPALTUNNELLARGE - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1)...
Creator: Customed, Inc
Published: 2014-05-20
License: https://open.fda.gov/license/

Customed, Inc / initiated 2014-05-20 / Terminated / root cause: packaging

FDA source

Customed, Inc began a recall of CARPALTUNNELLARGE - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) UTILITY BOWL 32oz LIF (2) DRAPE SHEET 41 " X 58"... on 2014-05-20. 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 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2348-2014
Classification: Class I
Status: Terminated
Initiated: 2014-05-20
Posted: 2014-08-29
Terminated: 2017-08-14
Recalling firm: Customed, Inc
Product: CARPALTUNNELLARGE - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) UTILITY BOWL 32oz LIF (2) DRAPE SHEET 41 " X 58" SMS (1) BANDAGE GAUZE 4" STRETCH (1) NEEDLE HYPODERMIC 25G X 5/8" (1) STOCKINETTE 6" X 48" LIF (2) CLOTH HUCK TOWEL BLUE (1) GOWN SMS LARGE NON REINFORCED TOWEL/WRAP (1) GOWN SURGICAL REINF XL TOWEL/WRAP (1) NEEDLE HYPODERMIC 18G X 1 %" (10) GAUZE SPONGE 4" X 4" 16PLY XRD L.F (1) UTILITY BOWL 16oz LIF (1) ABSORBENT TOWELS 15" X 20" LIF (1) CAST PADDING (2) SURGICAL BLADE #15 STAINLESS STEEL (4) DRAPE UTILITY WITH TAPE L/F (1) SHEET EXTREMITY ABS. 125" x 85" SMS EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Product code: OJH Orthopedic 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: 38 lots; 3066 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 900-742, 38 lots: 110092282 110112680 110122944 111010190 111020296 111041070 111061687 111071387 111071969 111082110 111092402 111102779 111113140 111123292 112010203 112020493 112030743 112041353 112052012 112062507 112093642 112104103 112114589 112125112 113015460 113025776 113025985 113036767 113067963 113068180 113088888 113099453 113109871 131110275 131210841 140111250 140211737 140311948

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2348-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2302-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2303-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2304-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2305-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2306-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2307-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2308-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2309-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2310-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2311-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2312-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2313-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2314-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2315-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2316-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2317-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2318-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2319-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2320-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2321-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2322-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2323-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2324-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2325-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2326-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2327-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2328-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2329-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2330-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2331-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2332-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2333-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2334-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2335-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2336-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2337-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2338-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2339-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2340-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2341-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2342-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2343-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2344-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2345-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2346-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2347-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2348-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2349-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2350-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2351-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2352-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2353-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2354-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2355-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2356-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2357-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2358-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2359-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2360-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2361-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2362-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2363-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2364-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2365-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2366-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2367-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2368-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2369-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2370-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2371-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2372-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2373-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2374-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2375-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2376-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2377-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2378-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2379-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2380-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2381-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2382-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2383-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2384-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2385-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2386-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2387-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2388-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2389-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2390-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2391-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2392-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2393-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2394-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2395-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2396-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2397-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2398-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2399-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2400-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2401-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2402-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2403-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2404-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2405-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2406-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2407-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2408-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2409-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2410-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2411-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2412-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2413-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2414-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2415-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2416-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2417-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2418-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2419-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2420-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2421-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2422-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2423-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2424-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2425-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2426-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2427-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2428-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2429-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2430-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2431-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2432-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2433-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2434-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2435-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2436-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2437-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2438-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2439-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2440-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2441-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2442-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2443-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2444-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2445-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2446-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2447-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2448-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2449-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2450-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2451-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2452-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2453-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2454-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2455-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2456-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2457-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2458-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2459-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2460-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2461-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2462-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2463-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2464-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2465-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2466-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2467-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2468-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2469-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2470-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2471-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2472-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2473-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2474-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2475-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2476-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2477-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2478-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2479-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2480-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2481-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2482-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2483-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2484-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2485-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2486-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2487-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2488-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2489-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2490-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2491-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2492-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2493-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2494-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2495-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2496-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2497-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2498-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2499-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2500-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29
Z-2501-2014	Class I	Terminated	Voluntary: Firm initiated	2014-09-10	2014-08-29

Product code OJH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)