| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | September 04, 2024 |
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| Date Posted | October 23, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0174-2025 |
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| Recall Event ID |
95415 |
| Product Classification |
Labor and Delivery Kit - Product Code MLS
|
| Product | Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF DYNJ0213264O;
2) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K;
3) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ0375486K;
4) VAGINAL DELIVERY, REF DYNJ04865M;
5) VAGINAL DELIVERY PACK-LF, REF DYNJ0536939R;
6) LABOR & DELIVERY-LF, REF DYNJ07831F;
7) DELIVERY PACK-LF, REF DYNJ09982A;
8) DELIVERY PACK-LF, REF DYNJ09982A;
9) DELIVERY ROOM PACK, REF DYNJ14193C;
10) OB PACK, REF DYNJ17486I;
11) OB PACK, REF DYNJ17486I;
12) DELIVERY PACK, REF DYNJ24339K;
13) DELIVERY PACK, REF DYNJ26935A;
14) DELIVERY PACK, REF DYNJ26935A;
15) OB/DELIVERY ROOM PACK, REF DYNJ27262F;
16) VAGINAL DELIVERY TRAY, REF DYNJ27275;
17) VAGINAL DELIVERY, REF DYNJ28437F;
18) OB PACK, REF DYNJ31817K;
19) OB PACK, REF DYNJ31817K;
20) OB PACK, REF DYNJ36010F;
21) OB PACK, REF DYNJ38804G;
22) VAGINAL PACK, REF DYNJ40037A;
23) VAGINAL DELIVERY, REF DYNJ40170A;
24) VAG RECTAL PACK BWH-LF, REF DYNJ41694B;
25) OB DELIVERY PACK, REF DYNJ41994;
26) DELIVERY BUNDLE KIT, REF DYNJ43370A;
27) DELIVERY ROOM PACK, REF DYNJ44328G;
28) OB PACK, REF DYNJ44500F;
29) DELIVERY PACK, REF DYNJ47621A;
30) OB PACK, REF DYNJ50482G;
31) DELIVERY PACK, REF DYNJ52966C;
32) DELIVERY PACK, REF DYNJ57567;
33) LABOR & DELIVERY PACK, REF DYNJ57598;
34) OB DELIVERY PACK, REF DYNJ60784B;
35) VAGINAL DELIVERY PACK, REF DYNJ61662;
36) VAGINAL DELIVERY PACK, REF DYNJ61662;
37) LABOR AND DELIVERY PACK, REF DYNJ61864A;
38) PK, L&D-VAG DEL-MH, REF DYNJ62512A;
39) PK, L&D-VAG DEL-MH, REF DYNJ62512A;
40) VUWC OB PACK, REF DYNJ64017B;
41) OB PACK, REF DYNJ65525B;
42) VAG DELIVERY PACK, REF DYNJ66415;
43) VAGINAL DELIVERY PACK, REF DYNJ66970;
44) VAG DELIVERY, REF DYNJ67089;
45) VAGINAL DELIVERY PACK, REF DYNJ67111;
46) VAGINAL DELIVERY PACK, REF DYNJ67111;
47) AOMC MIDWIFE PACK, REF DYNJ67588;
48) VAGINAL DELIVERY TRAY, REF DYNJ68131A;
49) DELIVERY L&D PACK-CLEAR LAKE, REF DYNJ68247C;
50) DELIVERY L & D PACK, REF DYNJ68251D;
51) DELIVERY L & D PACK, REF DYNJ68251D;
52) SS VAGINAL DELIVERY PACK, REF DYNJ69512;
53) VAGINAL DELIVERY PACK, REF DYNJ69544A;
54) DELIVERY, REF DYNJ69721;
55) VAGINAL PACK, REF DYNJ69774A;
56) LABOR & DELIVERY PACK, REF DYNJ69833;
57) VAGINAL DELIVERY, REF DYNJ80532A;
58) OB PACK, REF DYNJ81878;
59) VAGINAL DELIVERY DISP PACK, REF DYNJ81917;
60) GENERAL DELIVERY PACK, REF DYNJ82447;
61) VAGINAL DELIVERY PACK, REF DYNJ82489B;
62) OB PACK, REF DYNJ82923;
63) OB PACK III, REF DYNJ82945;
64) OB PACK, REF DYNJ83196;
65) OB PACK, REF DYNJ83515;
66) 3027240 OB DELIVERY PACK, REF DYNJ84730;
67) DELIVERY PACK, REF DYNJ85860;
68) LABOR AND DELIVERY, REF DYNJ907794A;
69) LABOR AND DELIVERY, REF DYNJ907794A;
70) LABOR AND DELIVERY, REF DYNJ907794A;
71) VAGINAL DELIVERY, REF DYNJ908636A;
72) LABOR & DELIVERY PK I-LF, REF DYNJT0104G;
73) PACK VAGINAL DELIVERY, REF HM190A;
74) VAGINAL DELIVERY PACK-LF, REF PHS410140008D;
75) VAGINAL DELIVERY PACK, REF SYNJ10248B;
76) VAGINAL DELIVERY PACK, REF SYNJ10248B |
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| Code Information |
1) REF DYNJ0213264O, UDI/DI 40193489411912 (each), 10193489411911 (case), Lot Numbers: 23LBP214;
2) REF DYNJ0375486K, UDI/DI 40889942232865 (each), 10889942232864 (case), Lot Numbers: 23LBQ906;
3) REF DYNJ0375486K, UDI/DI 40889942232865 (each), 10889942232864 (case), Lot Numbers: 23KBO506;
4) REF DYNJ04865M, UDI/DI 40195327188123 (each), 10195327188122 (case), Lot Numbers: 23LBP871;
5) REF DYNJ0536939R, UDI/DI 40195327206223 (each), 10195327206222 (case), Lot Numbers: 24ABC134;
6) REF DYNJ07831F, UDI/DI 40888277841131 (each), 10888277841130 (case), Lot Numbers: 24ABK556;
7) REF DYNJ09982A, UDI/DI 40888277860521 (each), 10888277860520 (case), Lot Numbers: 24ABE463;
8) REF DYNJ09982A, UDI/DI 40888277860521 (each), 10888277860520 (case), Lot Numbers: 23KBF261;
9) REF DYNJ14193C, UDI/DI 40195327410002 (each), 10195327410001 (case), Lot Numbers: 24ABA112;
10) REF DYNJ17486I, UDI/DI 40195327224388 (each), 10195327224387 (case), Lot Numbers: 23LBM930;
11) REF DYNJ17486I, UDI/DI 40195327224388 (each), 10195327224387 (case), Lot Numbers: 23KBF343;
12) REF DYNJ24339K, UDI/DI 40195327597352 (each), 10195327597351 (case), Lot Numbers: 24ABB322;
13) REF DYNJ26935A, UDI/DI 40080196655138 (each), 10080196655137 (case), Lot Numbers: 24ABF439;
14) REF DYNJ26935A, UDI/DI 40080196655138 (each), 10080196655137 (case), Lot Numbers: 23KBF264;
15) REF DYNJ27262F, UDI/DI 40195327302925 (each), 10195327302924 (case), Lot Numbers: 23LBR393;
16) REF DYNJ27275, UDI/DI 40080196833116 (each), 10080196833115 (case), Lot Numbers: 24ABF229;
17) REF DYNJ28437F, UDI/DI 40193489800518 (each), 10193489800517 (case), Lot Numbers: 23LBP215;
18) REF DYNJ31817K, UDI/DI 40195327502172 (each), 10195327502171 (case), Lot Numbers: 24ABE494;
19) REF DYNJ31817K, UDI/DI 40195327502172 (each), 10195327502171 (case), Lot Numbers: 24ABE736;
20) REF DYNJ36010F, UDI/DI 40195327409907 (each), 10195327409906 (case), Lot Numbers: 23KBO470;
21) REF DYNJ38804G, UDI/DI 40195327113101 (each), 10195327113100 (case), Lot Numbers: 24ABF285;
22) REF DYNJ40037A, UDI/DI 40889942253792 (each), 10889942253791 (case), Lot Numbers: 23KBD900;
23) REF DYNJ40170A, UDI/DI 40195327007981 (each), 10195327007980 (case), Lot Numbers: 24ABH933;
24) REF DYNJ41694B, UDI/DI 40193489662819 (each), 10193489662818 (case), Lot Numbers: 23KBI386;
25) REF DYNJ41994, UDI/DI 40884389912509 (each), 10884389912508 (case), Lot Numbers: 23KBM567;
26) REF DYNJ43370A, UDI/DI 40888277854124 (each), 10888277854123 (case), Lot Numbers: 24ABE458;
27) REF DYNJ44328G, UDI/DI 40195327165940 (each), 10195327165949 (case), Lot Numbers: 24ABA443;
28) REF DYNJ44500F, UDI/DI 40193489905497 (each), 10193489905496 (case), Lot Numbers: 24ABG242;
29) REF DYNJ47621A, UDI/DI 40193489203418 (each), 10193489203417 (case), Lot Numbers: 23LBM902;
30) REF DYNJ50482G, UDI/DI 40195327190188 (each), 10195327190187 (case), Lot Numbers: 24ABE007;
31) REF DYNJ52966C, UDI/DI 40193489237154 (each), 10193489237153 (case), Lot Numbers: 23LBP186;
32) REF DYNJ57567, UDI/DI 40889942753209 (each), 10889942753208 (case), Lot Numbers: 23LBP083;
33) REF DYNJ57598, UDI/DI 40889942756248 (each), 10889942756247 (case), Lot Numbers: 24ABN293;
34) REF DYNJ60784B, UDI/DI 40195327456444 (each), 10195327456443 (case), Lot Numbers: 23KBD079;
35) REF DYNJ61662, UDI/DI 40193489587303 (each), 10193489587302 (case), Lot Numbers: 24ABA680;
36) REF DYNJ61662, UDI/DI 40193489587303 (each), 10193489587302 (case), Lot Numbers: 23LBP067;
37) REF DYNJ61864A, UDI/DI 40195327213481 (each), 10195327213480 (case), Lot Numbers: 23LBM885;
38) REF DYNJ62512A, UDI/DI 40193489410007 (each), 10193489410006 (case), Lot Numbers: 23LBN089;
39) REF DYNJ62512A, UDI/DI 40193489410007 (each), 10193489410006 (case), Lot Numbers: 23KBC461;
40) REF DYNJ64017B, UDI/DI 40195327550326 (each), 10195327550325 (case), Lot Numbers: 24ABC789;
41) REF DYNJ65525B, UDI/DI 40195327403332 (each), 10195327403331 (case), Lot Numbers: 23LBP080;
42) REF DYNJ66415, UDI/DI 40193489353182 (each), 10193489353181 (case), Lot Numbers: 23KBE863;
43) REF DYNJ66970, UDI/DI 40193489384636 (each), 10193489384635 (case), Lot Numbers: 24ABA626;
44) REF DYNJ67089, UDI/DI 40193489385497 (each), 10193489385496 (case), Lot Numbers: 23KBF696;
45) REF DYNJ67111, UDI/DI 40193489387354 (each), 10193489387353 (case), Lot Numbers: 24ABB663;
46) REF DYNJ67111, UDI/DI 40193489387354 (each), 10193489387353 (case), Lot Numbers: 23KBB422;
47) REF DYNJ67588, UDI/DI 40193489416931 (each), 10193489416930 (case), Lot Numbers: 24ABE006;
48) REF DYNJ68131A, UDI/DI 40195327453849 (each), 10195327453848 (case), Lot Numbers: 23LBS187;
49) REF DYNJ68247C, UDI/DI 40195327507665 (each), 10195327507664 (case), Lot Numbers: 23KBF880;
50) REF DYNJ68251D, UDI/DI 40195327506460 (each), 10195327506469 (case), Lot Numbers: 23LBM746;
51) REF DYNJ68251D, UDI/DI 40195327506460 (each), 10195327506469 (case), Lot Numbers: 23KBE824;
52) REF DYNJ69512, UDI/DI 40193489949248 (each), 10193489949247 (case), Lot Numbers: 23LBP605;
53) REF DYNJ69544A, UDI/DI 40195327325368 (each), 10195327325367 (case), Lot Numbers: 23LBU620;
54) REF DYNJ69721, UDI/DI 40193489973076 (each), 10193489973075 (case), Lot Numbers: 24ABA088;
55) REF DYNJ69774A, UDI/DI 40195327328369 (each), 10195327328368 (case), Lot Numbers: 23KBM418;
56) REF DYNJ69833, UDI/DI 40193489983419 (each), 10193489983418 (case), Lot Numbers: 23LBP238;
57) REF DYNJ80532A, UDI/DI 40195327064649 (each), 10195327064648 (case), Lot Numbers: 23KBD408;
58) REF DYNJ81878, UDI/DI 40195327153572 (each), 10195327153571 (case), Lot Numbers: 23LBR963;
59) REF DYNJ81917, UDI/DI 40195327155347 (each), 10195327155346 (case), Lot Numbers: 24ABG346;
60) REF DYNJ82447, UDI/DI 40195327196951 (each), 10195327196950 (case), Lot Numbers: 23KBF548;
61) REF DYNJ82489B, UDI/DI 40195327361298 (each), 10195327361297 (case), Lot Numbers: 23LBJ943;
62) REF DYNJ82923, UDI/DI 40195327219421 (each), 10195327219420 (case), Lot Numbers: 24ABG248;
63) REF DYNJ82945, UDI/DI 40195327218868 (each), 10195327218867 (case), Lot Numbers: 23LBP176;
64) REF DYNJ83196, UDI/DI 40195327243976 (each), 10195327243975 (case), Lot Numbers: 24ABE294;
65) REF DYNJ83515, UDI/DI 40195327275045 (each), 10195327275044 (case), Lot Numbers: 24ABD211;
66) REF DYNJ84730, UDI/DI 40195327407712 (each), 10195327407711 (case), Lot Numbers: 23LBN461;
67) REF DYNJ85860, UDI/DI 40195327560233 (each), 10195327560232 (case), Lot Numbers: 23LBP250;
68) REF DYNJ907794A, UDI/DI 40195327482825 (each), 10195327482824 (case), Lot Numbers: 24EBF501;
69) REF DYNJ907794A, UDI/DI 40195327482825 (each), 10195327482824 (case), Lot Numbers: 24BBS293;
70) REF DYNJ907794A, UDI/DI 40195327482825 (each), 10195327482824 (case), Lot Numbers: 23KBT943;
71) REF DYNJ908636A, UDI/DI 40195327314980 (each), 10195327314989 (case), Lot Numbers: 23LBE142;
72) REF DYNJT0104G, UDI/DI 40889942741442 (each), 10889942741441 (case), Lot Numbers: 23LBL842;
73) REF HM190A, UDI/DI 40195327305162 (each), 10195327305161 (case), Lot Numbers: 23LBP164;
74) REF PHS410140008D, UDI/DI 40195327503131 (each), 10195327503130 (case), Lot Numbers: 23KBS958;
75) REF SYNJ10248B, UDI/DI 40193489373388 (each), 10193489373387 (case), Lot Numbers: 24ABA624;
76) REF SYNJ10248B, UDI/DI 40193489373388 (each), 10193489373387 (case), Lot Numbers: 23KBE181
|
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Karin Johnson
866-359-1704 |
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Manufacturer Reason
for Recall | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees. |
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| Quantity in Commerce | 12,583 units |
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| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Panama. |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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