Z-2385-2014Class I

PREMIUM O.B. PACK - CUSTOMED- (1) TABLE COVER REINFORCED 50" X 90" LIF (10) GAUZE SPONGES 4" X 4" 12PLY LIF...

Name: Z-2385-2014 PREMIUM O.B. PACK - CUSTOMED- (1) TABLE COVER REINFORCED 50" X 90" LIF (10) GAUZE SPONGES 4" X 4" 12PLY LIF...
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 PREMIUM O.B. PACK - CUSTOMED- (1) TABLE COVER REINFORCED 50" X 90" LIF (10) GAUZE SPONGES 4" X 4" 12PLY LIF (2) LEGGINS WITH 7" CUFF 30" x 42" LIF (2) PAD... 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-2385-2014
Classification: Class I
Status: Terminated
Initiated: 2014-05-20
Posted: 2014-08-29
Terminated: 2017-08-14
Recalling firm: Customed, Inc
Product: PREMIUM O.B. PACK - CUSTOMED- (1) TABLE COVER REINFORCED 50" X 90" LIF (10) GAUZE SPONGES 4" X 4" 12PLY LIF (2) LEGGINS WITH 7" CUFF 30" x 42" LIF (2) PAD OBSTETRICAL X-LARGE ST. (2) SHEET DRAPE 42" X 55" LIF (1) UNDERBUTTOCK DRAPE WITH POUCH LIF (1) DRAPE ABDOMINAL 40" X 54" WITH TAPE LIF (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF (1) BOWL PLASTIC 80oz WITH LID (1) EAR ULCER SYRINGE 2oz LIF (1) CORD UMBILICAL CLAMP LIF (1) BABY BLANKET IMP. 30" X 30" POLY ABS. LIF (1) TOWELS ABSORBENT 15" X 20" LIF (1) LAP SPONGE PRE-WASH 18" X 18" XRD LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Product code: OKV Obstetrical Kit
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: 44 lots; 4670 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 900-1297, 44 lots: 109030542 110061517 110071663 110081957 110082065 110082132 110112605 110112866 110123051 110123066 111030563 111071760 111082184 111082268 111092487 111102647 111102672 111112928 111112962 111123334 112010034 112020327 112041184 112062405 112062406 112062582 112062620 112083387 112114633 112124935 113015426 113025935 113036315 113036450 113047324 113068144 113078692 113109719 131110167 131110596 131210959 140111406 140412596 140513080

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2385-2014
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 OKV

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)