This notice is issued from MHRA, for the detailed information, Please check the below

0 URGENT FIELD SAFETY NOTICE

For Medex ™ Cardiothoracic Custom sets
Affected Devices: Attachment 1
Type of Action: Field Safety Corrective Action - Recall
Attention: Risk/ Safety Managers, Clinicians, Nurses and other users of the device
Details on affected devices: Product Reorder Codes: See Attachment 1
Lot Number: See Attachment 1: All lots within their expiration date
Dear Valued Customer:
Smiths Medical is providing this Urgent Field Safety Notice to advise its customers of a Field Safety Corrective Action for Cardiothoracic Custom sets. Smiths Medical is voluntarily initiating this Field Safety Corrective Action with the knowledge of the relevant Regulatory Agencies.
Smiths Medical has become aware of the potential for a small number of Cardiothoracic Custom sets to have punctures in the sterile breather bag packaging. This was discovered during performance of simulated distribution testing. Since these breather bags are used as a sterile barrier to maintain the device sterility, the potential risk is device sterility may be compromised.
Punctures in the blister packaging were identified during internal simulated distribution testing under extreme transportation conditions. Pin holes of around 0.2 mm were detected in the external packaging of products enclosed in protective wrapping. This wrapping material presents an additional sterility barrier therefore the likelihood that sterility may be compromised is very low. As a precautionary measure, Smiths Medical is advising its customers to return any unused affected products for credit or replacement.
Please also note the following: Smiths Medical has received no complaints or reports of patient injury related to this issue. Also, Smiths Medical‘s Instructions For Use states: “do not use if package is opened or damaged”.
2
As a precautionary measure all unexpired Lots of Product Reorder Codes listed in Attachment 1 are impacted by this Field Safety Corrective Action.
Advice on Action to be taken by the User:
1) Inspect your inventory for products on the attached list and contact Smiths Medical to discuss your options for replacement or credit at 0845 850 0445 ext. 2116 or email at ukcs@smiths-medical.com. Unfortunately, at this time, Smiths Medical anticipates supply constraints that may impact our ability to provide timely replacements.
2) Complete and return the Confirmation Form (Attachment 2), either by fax at +44 (0) 1233 722153 or by e-mail to WS25@smiths-medical.com within five (5) days of receipt of this notice.
Transmission of this Urgent Field Safety Notice
This notice shall be passed on to all personnel who need to be aware within your organization, including points of use or to any organization where the potentially affected devices have been transferred. If you, or your facility, has distributed these affected products to other persons or facilities, please promptly forward the recipients a copy of this Urgent Field Safety Notice.
Please maintain awareness of this Notice and resulting action for an appropriate period to ensure effectiveness of this Urgent Field Safety Corrective Action.
Customers should report any issues with these products to Smiths Medical’s Global Complaint Department at 00 800 76 48 47 00 or globalcomplaints@smiths-medical.com.
If you should have any questions regarding this information, please contact Smiths Medical’s Customer Service Department at 0845 850 0445 ext. 2116 or by email to WS25@smiths-medical.com
Smiths Medical is committed to providing quality products and service to its customers. We apologize for any inconvenience this situation may have caused.
Sincerely,
Marco Savino
Regional Director, Quality Systems Smiths Medical
Enclosures:
Attachment 1 – Product Reorder Codes and Lot Numbers
Attachment 2 – Field Safety Notice Confirmation Form
3
Product Reorder Number Lot Number
MX1680-61
2445264
2511291
2585333
SXP530850
2483712
2597624
SXP530852
2458362
2483838
2509962
2545189
SXP550271
2379590
2384326
2429255
2429694
2469860
2472195
2479723
2500036
2553899
2593962
2602000
2628537
2645680
2682518
2721239
2729173
2746669
2765179
2768797
2772037
2804580
2832880
2878151
2906704
2945598
2953924
2988621
2998522
3003950
3014307
3028218
3044504
3048870
3105079
SXP550280
2409964
2411976
2413656
2449740
2466733
Attachment 1- Affected Product Reorder Codes and Associated Lot Numbers
4
SXP550289
2379591
2392782
2425032
2438872
2479518
2488460
2505345
2540649
2558546
SXP550308
2388401
2397821
2411960
2415964
2462690
2513825
2523985
2553876
2553895
2589031
2611855
2632181
2655224
2663066
2692177
2702322
2726521
2735096
2746670
2770604
2802006
2821715
2850588
2878149
2878150
2899752
2906706
2940270
2962709
2973162
2986212
3001615
3031056
3105080
5
SXP550311
*******
2420739
2454374
2467045
2479724
2496736
2509963
2523986
2532822
2549564
2563083
2581013
2607595
2615627
2628535
2632182
2650404
2672095
2686766
2697143
2712255
2713876
2726450
2735094
2751591
2765184
2768798
2778321
2798391
2804579
2844561
2878147
2886345
2895586
2913330
2936126
2949458
2960307
2966826
2979843
2988589
3001616
3005914
3028217
3031058
3040369
3048873
SXP550324
*******
2409961
2458043
2483840
2509918
2536650
6
SXP550384
2411961
2425031
2458027
2469862
2488461
2520470
2536584
2558439
2628534
2650403
2678147
2729522
2735093
2790987
2798390
2850590
2913331
2969738
3031059
SXP570799
2368687
2411968
2524014
2640564
2674044
2731426
2735091
SXP580603
2416899
2462688
SXP580637
2384327
2411967
SXP590230A
2388330
2425308
2454375
2483830
2500048
2505343
2513823
2540650
2558547
2576570
2585332
2597662
2620862
2628542
2640970
2655226
2682515
2716799
2726456
2742190
2751595
2794238
2804475
2804578
2844560
2852377
2879385
2902108
2911080
2924564
7
2926921
2949480
2963482
2977157
3001617
3003951
SXP630261
2388329
2443906
2459910
2479725
2505344
2516127
2520473
2537703
2558542
2567135
2572815
2597626
2607599
2659164
2686904
2702320
2724223
2740169
2764826
2776219
2802007
2821717
2852378
2889377
2895587
2906742
2936128
2971755
2991537
2993963
3005915
3014309
3031060
3044507
SXP650203
2438875
2462689
2520474
2537704
2572814
2620870
2672643
2844559
2995776
8
SXP650246
2388397
2416900
2449744
2475411
2479732
2524058
2584867
2589037
2642819
2649996
2654638
2659161
2678148
2692167
2716801
2731427
2746672
2776221
2791099
2913333
2931517
2947856
2960308
3001618
3001619
3035391
SXP700420
*******
2466729
2509970
2536577
2558548
2597623
2628540
2696666
2804476
2896011
2913335
3109316
9
SXP700421
2374691
2388400
2397762
2411974
2415966
2459913
2471579
2471580
2471581
2483831
2488462
2500037
2509959
2513826
2536586
2545205
2549561
2563107
2584874
2589039
2611856
2611857
2615628
2631960
2654706
2659539
2692170
2702321
2969737
3003954
SXP700427
2343852
2374682
2397817
2415967
2458038
SXP720114
2369149
2379595
2388396
2392784
2397818
2443910
2453955
2454027
2459906
2475733
2479726
2488463
2500038
2505346
10
SXP720188
2413746
2425034
2434789
2458045
2469855
2481146
2488458
2492444
2497806
2506232
2520476
2537707
2563487
2563488
2572813
2581012
2586167
2589033
2602743
2611861
2624460
2640969
2655222
2663411
2672642
2678152
2702318
2716798
2726451
2726517
2744171
2746768
2748685
2765185
2768129
2776222
2780741
2790988
2798389
2852380
2889378
2899753
2908811
2926942
2953950
2969734
2979844
2982001
3001620
3018630
3022261
3028215
3047888
3048875
11
SXP720323
2392785
2411978
2429262
2457998
2479213
2506233
2536578
2576575
2589054
2667944
2711896
2733482
2765186
2784639
12
SXP720369
2392786
2394161
2397819
2411972
2415960
2420740
2425030
2429252
2434110
2438867
2443908
2466734
2469857
2479523
2479524
2479728
2479729
2482885
2483832
2488464
2496735
2500040
2505347
2509964
2513881
2519334
2523993
2523994
2523995
2524065
2532828
2536579
2537708
2540645
2545210
2553897
2561570
2567137
2567138
2567139
2572816
2581011
2585325
2585326
2589038
2589058
2597663
2602744
2607087
2611670
2612346
2612347
2620865
2620866
2624022
2624463
2631954
2632091
2645681
2645682
13
2645686
2650401
2655228
2679309
2684628
2689613
2697138
2697139
2704453
2707830
2711918
2714176
2716800
2726518
2726519
2729188
2731430
2735090
2740170
2744172
2751254
2751596
2765187
2770605
2774439
2777160
2777161
2778322
2778323
2790989
2791100
2791101
2794239
2794240
2804575
2804577
2819133
2821718
2825052
2832879
2844558
2850591
2861397
2871261
2879384
2883670
2886347
2889621
2895588
2902110
2906743
2911081
2913336
14
2926102
2926943
2931525
2934886
2938212
2943139
2947857
2953953
2956083
2956084
2962716
2965766
2977156
2979845
2979846
2979847
2988576
2988591
2988623
2993965
3001621
3001622
3005916
3005917
3009837
3014310
3018631
3023580
3028214
3035392
3035393
3044508
3044509
3044510
3044511
3048876
3053025
3053026
SXP720471
2384332
2388325
2388326
2388327
2392779
2425033
2425317
2450421
2457999
2466735
2469864
2479525
SXP720584
2388834
SXP720629
2392787
2457995
2514011
2563489
2564510
2576578
2649999
2721111
2742197
15
2797776
SXP720682
2413141
2415974
2466736
2516133
2589086
2620327
2701537
2726520
2821337
2883659
3009839
SXP720714
2374685
2384333
2388399
2397824
2415975
2458000
2466730
2479731
2483834
SXP720728
2411973
2425035
2448867
2457996
2483835
2524068
2540651
2567134
2615388
2655227
2707828
2721240
2751252
2790990
2832721
2871262
2895592
2929010
2995781
3044512
16
SXP720896
2392777
2411966
2425036
2459914
2765190
2780761
2844360
2879383
2881586
2885061
2895623
2524070
2664509
2712257
2733483
2852379
3009842
SXP721355
2476088
2488465
2540648
2558549
2667495
2692174
2746767
2751258
2765829
2772057
2871263
2938214
2995782
3031061
3083158
SXP721438
2466731
2470867
2483837
2540646
2558444
SXP721442
2466732
2488459
2519336
2519337
SXP721461
2624459
2706550
2712895
2726516
2728837
2737566
2740187
2787144
2819132
2822095
2873427
2949469
2988624
3011822
3037866
3101355
2501322
17
SXP721494
2501326
2505327
2509965
2513884
2524000
2524071
2536582
2553896
2553898
2567132
2576576
18

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