Z-2528-2014Class I

Laparoscopy pack, , Code 900-3178, contains: (1) BULB SYRINGE 60cc LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD...

Name: Z-2528-2014 Laparoscopy pack, , Code 900-3178, contains: (1) BULB SYRINGE 60cc LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD...
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 Laparoscopy pack, , Code 900-3178, contains: (1) BULB SYRINGE 60cc LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE... 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-2528-2014
Classification: Class I
Status: Terminated
Initiated: 2014-05-20
Posted: 2014-08-29
Terminated: 2017-08-14
Recalling firm: Customed, Inc
Product: Laparoscopy pack, , Code 900-3178, contains: (1) BULB SYRINGE 60cc LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (3) GOWN SURG REINFORCED XL EXTRA LONG LEVEL IV (4) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE VIDEO CAMERA 13cm X 244cm LIF (3) LITE GLOVE LIF (1) DRAPE LAP ABDOMINAL W/POUCH 102" X 122" X 78" (1) BLADE SURGICAL# 11 (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE LIF (1) SUTURE BAG FLORAL L/F (1) NEEDLE & BLADE COUNTER 10c MAG/CLEAR LIF (1) CABLE LAP 10FR 4MM MALE MONOP. LIF (1) SPECIMEN CONTAINER 4oz W/LID & LABEL (2) SHEET% 60" X 77" DRAPE REINFORCED LIF (1) TUBING INSUFFLATION SET W/0 RING ADAPTOR LIF (1) WRAPPER 24" X 24" LIF (1) ULTRA VERES NEEDLE 120MM LIF (1) TROCAR ENDO.XCELL DILATING TIP 11 MM (1) TROCAR ENDO.XCELL DILATING TIP 5MM LIF (1) CANNULA 5MM XCEL SLEEVES LIF (2) DENTURE CUP 8oz W/LID (2) DRESSING NON ADH TELFA 4" X 3" (1) CHLORAPREP 26ML APPLICATOR TEAL LIF Product Usage: 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: 4 lots/ 154 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: 900-3178, 4 lots: 131210899 140211837 140312152 140513143

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2528-2014
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)