Z-2377-2014Class I

LAP AROSCOPY PACK - (10) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) MAYO STAND COVER REINFORCED L/F (4) ADHESIVE...

Name: Z-2377-2014 LAP AROSCOPY PACK - (10) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) MAYO STAND COVER REINFORCED L/F (4) ADHESIVE...
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 LAP AROSCOPY PACK - (10) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) MAYO STAND COVER REINFORCED L/F (4) ADHESIVE BANDAGE%" X 3" ST. LIF (1) TABLE COVER REINFORCED... 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-2377-2014
Classification: Class I
Status: Terminated
Initiated: 2014-05-20
Posted: 2014-08-29
Terminated: 2017-08-14
Recalling firm: Customed, Inc
Product: LAP AROSCOPY PACK - (10) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) MAYO STAND COVER REINFORCED L/F (4) ADHESIVE BANDAGE%" X 3" ST. LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (2) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE LASER CAMERA W/EL 6" X 96" LIF (2) LITE GLOVE LIF (1) TUBE SUCTION CONNECTING W X 12' LIF (1) DRAPE LAP WITH POUCH 102" X 121 " X 78" STD SMS (1) BLADE SURGICAL #11 STAINLESS STEEL (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE L/F (1) BAG SUTURE FLORAL (1) TUR Y SET, 2 LEAD L/F (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR LIF (1) GOWN STANDARD LARGE SMS VELCRO NECK (1) TUBE SUCTION CONNECT 3/16" X 12' LIF (1) Pk. STERI STRIP LAP. LATEX (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) CAUTERY PENCIL ROCKER SWITCH LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Product code: FDE Laparoscopy 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: 21 lots; 690 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 900-1176, 21 lots: 112051673 112051735 112062336 112083210 112093723 112114597 112114925 113025928 113036747 113078239 113078679 113089017 113099562 140111074 140211461 140211717 140312052 140312421 140412913 140513071 140513476

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2377-2014
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 FDE

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)