Z-2421-2014Class I

UNIVERSAL PACK - (1) UTILITY BOWL 16oz. (1) NEEDLE SPINAL ANEST. 22G X 31!2 (1) SYRINGE 5cc WITHOUT NEEDLE...

Name: Z-2421-2014 UNIVERSAL PACK - (1) UTILITY BOWL 16oz. (1) NEEDLE SPINAL ANEST. 22G X 31!2 (1) SYRINGE 5cc WITHOUT NEEDLE...
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 UNIVERSAL PACK - (1) UTILITY BOWL 16oz. (1) NEEDLE SPINAL ANEST. 22G X 31!2 (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF (2) SYRINGE 10ccWITHOUT NEEDLE LUER... 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-2421-2014
Classification: Class I
Status: Terminated
Initiated: 2014-05-20
Posted: 2014-08-29
Terminated: 2017-08-14
Recalling firm: Customed, Inc
Product: UNIVERSAL PACK - (1) UTILITY BOWL 16oz. (1) NEEDLE SPINAL ANEST. 22G X 31!2 (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 20G X 1 1!2 (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMIIII (1) SPLIT SHEET WITH ADHESIVE 108" X 77" SMS STD LIF (1) DRAPE % ECONOMY 53" X 77" UF (2) TOWEL ABSORBENT 15" X 20" UF (4) DRAPE UTILITY WITH TAPE LIF (1 0) GAUZE SPONGES 4" X 4" 12PL Y (4) TOWELS CLOTH HUCK BLUE (1) TABLE COVER REINFORCED 50" X 90" UF (1) SCALPEL WITH HANDLE #11 (3) PK. CLOSURE SKIN W' X 4" STERI STRIP UF (1) SKIN MARKER WITH RULER (1) DENTURE CUP 8oz WITH LID (1) NEEDLE HYPODERMIC 25 X 1 1!2 (1) STOCKINETTE IMPERVIOUS 14" X 48" (2) TIP ABSORB. APPLICATOR STICK SPONGE (1) TRAY ORGANIZER FULL DEEP (1) TRA 2/COMPARTMENT (1) RULER L/F 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: 22 lots; 312 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 900-1936, 22 lots: 110082088 110082207 110102439 110112627 110112928 111010082 111030630 111041100 111051372 111061520 111071785 111113056 111123422 112010103 112041214 112062469 112083415 113109769 131210637 140111090 140312098 140412891

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2421-2014
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 LRO

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)