| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | October 09, 2024 |
|---|
| Date Posted | December 05, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0643-2025 |
|---|
| Recall Event ID |
95621 |
| Product Classification |
Gynecological laparoscopic kit - Product Code OHD
|
| Product | MEDLINE convenience kits labeled as:
1) GYN LAPAROSCOPY-LF, REF CDS760059I;
2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S;
3) GYN MAJOR, REF CDS980998L;
4) ROBOTIC PROCEDURE, REF CDS982128P;
5) ROBOTIC, REF CDS984262N;
6) GYN LAPAROSCOPY, REF CDS984900M;
7) GYN LAPAROSCOPY, REF CDS984900N;
8) DAVINCI PACK-LF, REF DYNJ0101304G;
9) PROSTATE ROBOTIC PACK, REF DYNJ0347372J;
10) URO GYN PACK-LF, REF DYNJ17454N;
11) DB DAVINCI ROBOT PACK-LF, REF DYNJ33592I;
12) ROBOTIC UROLOGY-RF, REF DYNJ38844N;
13) TLH PACK, REF DYNJ42792D;
14) SVMMC GEN ROBOTIC PACK, REF DYNJ43770L;
15) SVMMC ROBOTIC KIDNEY PACK, REF DYNJ43778L;
16) SVMMC GYN ROBOTIC PACK, REF DYNJ43782K;
17) SVMMC ROBOTIC PROSTATE PACK, REF DYNJ43862J;
18) DA VINCI HYSTERECTOMY, REF DYNJ44863O;
19) DA VINCI PROSTATE/COLPOPEXY, REF DYNJ44864S;
20) LAP-GYN PACK, REF DYNJ44876L;
21) LAP-GYN PACK, REF DYNJ44876M;
22) ROBOT PACK, REF DYNJ45184F;
23) GYN ROBOTIC PACK, REF DYNJ47766Q;
24) ST. ANNE'S MULTI PORT PACK, REF DYNJ48638G;
25) RBTC COLON/KIDNEY PK RFID-LF, REF DYNJ52397M;
26) GYN LAP PACK, REF DYNJ52524C;
27) ROBOTIC PACK, REF DYNJ53650D;
28) LAPAROTOMY PACK, REF DYNJ59079D;
29) ROBOTIC GYN PACK, REF DYNJ62107B;
30) GYN UROL BASIC LAPAROSCOPY, REF DYNJ63326D;
31) FAIRFAX DAVINCI TRAY, REF DYNJ63606C;
32) GYN LAP PACK, REF DYNJ64234B;
33) ROBOT GYN SHARED, REF DYNJ64793A;
34) ROBOT GYN SHARED, REF DYNJ64793B;
35) ROBOT GYN SHARED, REF DYNJ64793C;
36) GYN DAVINCI PACK, REF DYNJ65373A;
37) ROBOT PACK, REF DYNJ67190C;
38) TUBAL LIGATION PACK, REF DYNJ68563A;
39) TUBAL LIGATION PACK, REF DYNJ68563B;
40) DAVINCI GYN PACK, REF DYNJ69169A;
41) GYN LAPAROSCOPY PACK, REF DYNJ69490C;
42) ROBOTIC PACK, REF DYNJ84776A;
43) ROBOTIC LAVH, REF DYNJ901281G;
44) ROBOTIC LAP CHOLE, REF DYNJ901282J;
45) GYN LAPAROTOMY, REF DYNJ902498J;
46) WMC ROBOTIC BASE-LF, REF DYNJ902583M;
47) HHI ROBOTIC CDS, REF DYNJ902953G;
48) HHI ROBOTIC CDS, REF DYNJ902953I;
49) HHI ROBOTIC CDS, REF DYNJ902953J;
50) HHI ROBOTIC CDS, REF DYNJ902953K;
51) ROBOTIC GYN & GU, REF DYNJ903459F;
52) SM DAVINCI, REF DYNJ903539G;
53) WEST GYN LAPAROSCOPY, REF DYNJ904490I;
54) ROBOTIC GYN, REF DYNJ904792C;
55) ROBOTIC GENERAL, REF DYNJ904793B;
56) ROBOT, REF DYNJ906112B;
57) ROBOTIC URO LH, REF DYNJ906445A;
58) ROBOTIC URO LH, REF DYNJ906445B;
59) ROBOTIC URO LH, REF DYNJ906445C;
60) WMC THORACIC ROBOTIC, REF DYNJ907153C;
61) DAVINCI, REF DYNJ907392A;
62) DAVINCI, REF DYNJ907392B;
63) DAVINCI ROBOTICS-HERNIA, REF DYNJ907396B;
64) DAVINCI ROBOTICS-HERNIA, REF DYNJ907396C;
65) GYN LAPAROSCOPY - NTSC, REF DYNJ907407A;
66) GYN LAPAROSCOPY - NTSC, REF DYNJ907407B;
67) ROBOTIC-LF, REF DYNJ907910;
68) ROBOTIC-LF, REF DYNJ907910A;
69) GU DAVINCI KIT, REF DYNJ908783;
70) GU DAVINCI KIT, REF DYNJ908783A;
71) GU DAVINCI PACK - LF, REF DYNJ909398A;
72) GYN LAPAROSCOPY, REF DYNJ910084;
73) MHPB GYN ROBOTIC PACK, REF DYNJ910125; |
|---|
| Code Information |
85OHD,
1) REF CDS760059I, UDI/DI 10195327009526 (each) 40195327009527 (case), Lot Numbers: 22KBT168, 22GBJ110, 22FBO228, 22FBN206, 23ABM526;
2) REF CDS920099S, UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 22EBA153, 23HBS831, 23GBT006, 23ABF835, 23ABE852, 23ABC459, 22IBE827, 22GBP098;
3) REF CDS980998L, UDI/DI 10193489232837 (each) 40193489232838 (case), Lot Numbers: 23HBS764, 24CBA346, 24BBO669;
4) REF CDS982128P, UDI/DI 10195327491659 (each) 40195327491650 (case), Lot Numbers: 23JBV057;
5) REF CDS984262N, UDI/DI 10195327241735 (each) 40195327241736 (case), Lot Numbers: 23ABN752, 23ABH001, 23CBU637, 23EBG216, 23FBL899;
6) REF CDS984900M, UDI/DI 10195327265670 (each) 40195327265671 (case), Lot Numbers: 23EBA735;
7) REF CDS984900N, UDI/DI 10195327448417 (each) 40195327448418 (case), Lot Numbers: 23JBT539, 24ABT539;
8) REF DYNJ0101304G, UDI/DI 10195327351663 (each) 40195327351664 (case), Lot Numbers: 23GDA822, 23CDA336;
9) REF DYNJ0347372J, UDI/DI 10195327555245 (each) 40195327555246 (case), Lot Numbers: 24CBN143, 24DBI923;
10) REF DYNJ17454N, UDI/DI 10195327491604 (each) 40195327491605 (case), Lot Numbers: 23JBR958;
11) REF DYNJ33592I, UDI/DI 10195327469559 (each) 40195327469550 (case), Lot Numbers: 23IDC293;
12) REF DYNJ38844N, UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 23DBB947, 23CBN366, 23EBW814, 23BBD619, 23DBI585;
13) REF DYNJ42792D, UDI/DI 10195327653514 (each) 40195327653515 (case), Lot Numbers: 24CBA980;
14) REF DYNJ43770L, UDI/DI 10193489989991 (each) 40193489989992 (case), Lot Numbers: 22IBC524, 22JBT938, 23GBN441, 23KBE916, 23JBJ792, 24ABW049, 24BBJ418, 23DBB305, 22LBI806, 22LBI807, 23ABM291, 23EBT683, 23DBM687, 24CBK840, 24CBA672;
15) REF DYNJ43778L, UDI/DI 10193489990133 (each) 40193489990134 (case), Lot Numbers: 22EBR178, 22DBI437, 22GBK246, 23BBG028, 23FBD832, 23DBB308, 23GBN442, 23LBN691, 24BBK830;
16) REF DYNJ43782K, UDI/DI 10193489989892 (each) 40193489989893 (case), Lot Numbers: 22GBK022, 22JBM498, 22IBD372, 22KBO079, 23JBN680, 23KBK083, 24BBM541, 24ABN836, 24EBE613;
17) REF DYNJ43862J, UDI/DI 10193489990157 (each) 40193489990158 (case), Lot Numbers: 22LLA203, 22JLB142, 22ILA238, 22KLA975, 23ALA636, 23DLA332, 23BLA068, 23FLA225, 23HLA685, 23GLB210, 23KLA370, 23GLA459, 24BLA720, 24ALA170, 23JLA444, 23ILA920, 24DLA220;
18) REF DYNJ44863O, UDI/DI 10195327127619 (each) 40195327127610 (case), Lot Numbers: 22HDB157;
19) REF DYNJ44864S, UDI/DI 10195327127626 (each) 40195327127627 (case), Lot Numbers: 22GBA089, 23DBR620, 22HBY159, 22EBC670, 23BBV092;
20) REF DYNJ44876L, UDI/DI 10195327127695 (each) 40195327127696 (case), Lot Numbers: 22HDB217;
21) REF DYNJ44876M, UDI/DI 10195327298418 (each) 40195327298419 (case), Lot Numbers: 22LDB769, 23CDA215, 23CDA612;
22) REF DYNJ45184F, UDI/DI 10195327191474 (each) 40195327191475 (case), Lot Numbers: 22FBW406, 22JBD483, 23BBK976, 23CBT915;
23) REF DYNJ47766Q, UDI/DI 10195327270001 (each) 40195327270002 (case), Lot Numbers: 23GDA728;
24) REF DYNJ48638G, UDI/DI 10195327109158 (each) 40195327109159 (case), Lot Numbers: 22DBQ919, 23DBB019, 23CBH108, 23ABL241, 23GBM672;
25) REF DYNJ52397M, UDI/DI 10195327339098 (each) 40195327339099 (case), Lot Numbers: 23EDC260;
26) REF DYNJ52524C, UDI/DI 10889942796915 (each) 40889942796916 (case), Lot Numbers: 23CMF377;
27) REF DYNJ53650D, UDI/DI 10195327337643 (each) 40195327337644 (case), Lot Numbers: 23GBT276, 23IBU040, 24ABC282, 24BBH893, 23FBR552, 23IBA185;
28) REF DYNJ59079D, UDI/DI 10195327200251 (each) 40195327200252 (case), Lot Numbers: 22LBL494, 22GBY139, 23ABL800, 23ABB585, 23CBV720, 23JBT579, 23IBM532;
29) REF DYNJ62107B, UDI/DI 10195327350895 (each) 40195327350896 (case), Lot Numbers: 23FBE253;
30) REF DYNJ63326D, UDI/DI 10195327094409 (each) 40195327094400 (case), Lot Numbers: 22JMC433, 22JMC435, 22DBM777;
31) REF DYNJ63606C, UDI/DI 10193489900248 (each) 40193489900249 (case), Lot Numbers: 22FBV006, 23BBC458, 23FBF843, 23JBP024;
32) REF DYNJ64234B, UDI/DI 10193489382655 (each) 40193489382656 (case), Lot Numbers: 22GMB743, 22LMF980;
33) REF DYNJ64793A, UDI/DI 10193489457391 (each) 40193489457392 (case), Lot Numbers: 22GDA994;
34) REF DYNJ64793B, UDI/DI 10195327217914 (each) 40195327217915 (case), Lot Numbers: 23IDA919, 23LDB556, 23ADB401, 22KDB707, 23CDC139, 23CDA142;
35) REF DYNJ64793C, UDI/DI 10195327639075 (each) 40195327639076 (case), Lot Numbers: 24CDA102;
36) REF DYNJ65373A, UDI/DI 10195327417987 (each) 40195327417988 (case), Lot Numbers: 23FMD177;
37) REF DYNJ67190C, UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23BBC622, 22LBO811, 23BBM118, 23DBK217;
38) REF DYNJ68563A, UDI/DI 10193489994841 (each) 40193489994842 (case), Lot Numbers: 23GBW287;
39) REF DYNJ68563B, UDI/DI 10195327511791 (each) 40195327511792 (case), Lot Numbers: 24ABC442, 24ABP074;
40) REF DYNJ69169A, UDI/DI 10195327156480 (each) 40195327156481 (case), Lot Numbers: 23AME723, 23AMA205;
41) REF DYNJ69490C, UDI/DI 10195327243913 (each) 40195327243914 (case), Lot Numbers: 23GDA238;
42) REF DYNJ84776A, UDI/DI 10195327615987 (each) 40195327615988 (case), Lot Numbers: 24DME593, 24BMG248, 24BMB085, 24CMC391, 24CMK067;
43) REF DYNJ901281G, UDI/DI 10195327349066 (each) 40195327349067 (case), Lot Numbers: 23GBU141;
44) REF DYNJ901282J, UDI/DI 10195327349202 (each) 40195327349203 (case), Lot Numbers: 23GBF221, 23GBF801, 23JBU677;
45) REF DYNJ902498J, UDI/DI 10195327336424 (each) 40195327336425 (case), Lot Numbers: 23GBJ197, 23FBK861;
46) REF DYNJ902583M, UDI/DI 10195327600952 (each) 40195327600953 (case), Lot Numbers: 24BBU793;
47) REF DYNJ902953G, UDI/DI 10195327118075 (each) 40195327118076 (case), Lot Numbers: 22HMA128;
48) REF DYNJ902953I, UDI/DI 10195327216597 (each) 40195327216598 (case), Lot Numbers: 22JMC312;
49) REF DYNJ902953J, UDI/DI 10195327296254 (each) 40195327296255 (case), Lot Numbers: 22LMA416, 23AMA855, 23CMB170;
50) REF DYNJ902953K, UDI/DI 10195327488710 (each) 40195327488711 (case), Lot Numbers: 23HMG988, 24AMA644, 23LMA536, 23IMD748, 24DMK165, 24CMH773, 24BMF820, 23IMD761, 24EMG520, 24EMB536, 24FMJ241;
51) REF DYNJ903459F, UDI/DI 10195327200374 (each) 40195327200375 (case), Lot Numbers: 22KBR937, 23EBG039, 23BBK004, 23FBT549, 23HBV186, 23IBC012;
52) REF DYNJ903539G, UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23GMB348;
53) REF DYNJ904490I, UDI/DI 10195327186326 (each) 40195327186327 (case), Lot Numbers: 23ABJ533;
54) REF DYNJ904792C, UDI/DI 10195327072803 (each) 40195327072804 (case), Lot Numbers: 23HDC090, 23CDB391;
55) REF DYNJ904793B, UDI/DI 10195327072650 (each) 40195327072651 (case), Lot Numbers: 22GDA529, 23GDB165, 23HDA865, 23JDC274;
56) REF DYNJ906112B, UDI/DI 10195327597375 (each) 40195327597376 (case), Lot Numbers: 24BBH136, 24DBT158, 24DBV357;
57) REF DYNJ906445A, UDI/DI 10195327167288 (each) 40195327167289 (case), Lot Numbers: 22GBJ176;
58) REF DYNJ906445B, UDI/DI 10195327228392 (each) 40195327228393 (case), Lot Numbers: 23EBT765, 23EBF127;
59) REF DYNJ906445C, UDI/DI 10195327436414 (each) 40195327436415 (case), Lot Numbers: 23JBM489, 23HBV246, 23JBW647, 24BBK908, 24BBQ096, 24DBL767;
60) REF DYNJ907153C, UDI/DI 10195327600778 (each) 40195327600779 (case), Lot Numbers: 24GBT128, 24EBE754;
61) REF DYNJ907392A, UDI/DI 10195327329525 (each) 40195327329526 (case), Lot Numbers: 23CMA009, 23FMI177, 23CMB744, 23GMC935;
62) REF DYNJ907392B, UDI/DI 10195327462338 (each) 40195327462339 (case), Lot Numbers: 23JMC266;
63) REF DYNJ907396B, UDI/DI 10195327329532 (each) 40195327329533 (case), Lot Numbers: 23DMA650, 23BME717, 23BME738, 23GMC937, 23FMC911, 23GMH664, 23FMA674;
64) REF DYNJ907396C, UDI/DI 10195327462352 (each) 40195327462353 (case), Lot Numbers: 23IMF381, 23JME981;
65) REF DYNJ907407A, UDI/DI 10195327335809 (each) 40195327335800 (case), Lot Numbers: 23EME041;
66) REF DYNJ907407B, UDI/DI 10195327462208 (each) 40195327462209 (case), Lot Numbers: 23HMF546;
67) REF DYNJ907910, UDI/DI 10193489941807 (each) 40193489941808 (case), Lot Numbers: 22EBI105, 22IBM319, 22EBG580, 22EBE690, 22EBF759;
68) REF DYNJ907910A, UDI/DI 10195327225155 (each) 40195327225156 (case), Lot Numbers: 23CBN033, 22KBT244;
69) REF DYNJ908783, UDI/DI 10195327183301 (each) 40195327183302 (case), Lot Numbers: 23CDB746, 23FDB402, 23DDC292, 23HDC431;
70) REF DYNJ908783A, UDI/DI 10195327520267 (each) 40195327520268 (case), Lot Numbers: 23KMF011, 23LMC664;
71) REF DYNJ909398A, UDI/DI 10195327338190 (each) 40195327338191 (case), Lot Numbers: 23HME512, 23KME175, 23JMB528, 23HMI269, 24EMC327, 24HMG886;
72) REF DYNJ910084, UDI/DI 10195327568993 (each) 40195327568994 (case), Lot Numbers: 24ABI431, 23LBT816, 24EBD996;
73) REF DYNJ910125, UDI/DI 10195327594930 (each) 40195327594931 (case), Lot Numbers: 24DBF506
|
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Haley Barclay
866-359-1704 |
|---|
Manufacturer Reason
for Recall | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/11/2024 via mail and email. The notice explained the problem with the Stryker component, potential risk, requested the kits be quarantined pending additional labeling and o respond through their portal: https://recalls.medline.com. Once the response is received, Medline will provide additional labeling to be applied to the affected kits which states the following: "Attention: R-24-219, This kit contains a recalled item, STRYKER SafeAir Smoke Evacuation Pencil, VPN: 0703-047-000, 0703-047-001, 0703-047-002, 0703-046-000, 0703-046-001, 0703-046-002. DO NOT USE THIS COMPONENT. The rest of the kit may be used. Please remove this item only and replace with product from supply. *Do not cover or remove this sticker*".
Those further distributing the product were directed to notify their customers.
|
|---|
| Quantity in Commerce | 13057 units |
|---|
| Distribution | US Nationwide distribution. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
|
|
|
