| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | April 08, 2024 |
|---|
| Date Posted | September 06, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-3041-2024 |
|---|
| Recall Event ID |
94583 |
| Product Classification |
Lumbar puncture tray (adult & pediatric) - Product Code PWY
|
| Product | Medline Convenience kits labeled as:
1) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063;
2) PULL D/C PACK, Pack Number DYNDA2080;
3) STERILE 3CC SYR W/ 23GX1 NDL, Pack Number DYNDA2495;
4) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497;
5) ARTHROGRAM TRAY, Pack Number DYNDH1113;
6) ARTHROGRAM TRAY, Pack Number DYNDH1134;
7) BIOPSY TRAY, Pack Number DYNDH1137C;
8) BREAST BIOPSY TRAY, Pack Number DYNDH1257;
9) OHS CT BIOPSY TRAY -LF, Pack Number DYNDH1270;
10) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1275;
11) ISHAK I.R. BIOPSY TRAY, Pack Number DYNDH1297;
12) ISHAK IR DRAINAGE TRAY, Pack Number DYNDH1300;
13) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319;
14) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1321;
15) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324B;
16) DIAGNOSTIC TRAY, Pack Number DYNDH1359;
17) LUMBAR TRAY, Pack Number DYNDH1500;
18) TRAY SAFETY LUMBAR PUNCTURE 18GX3.5, Pack Number DYNDH1538;
19) TRAY SAFETY LUMBAR PUNCTURE 20GX3.5, Pack Number DYNDH1539;
20) LUMBAR TRAY, Pack Number DYNDH1540;
21) LUMBAR TRAY, Pack Number DYNDH1540A;
22) BIOPSY PACK, Pack Number DYNDH1556B;
23) BIOPSY KIT, Pack Number DYNDH1570;
24) MYELOGRAM TRAY, Pack Number DYNDH1574;
25) BIOPSY BASIC PACK, Pack Number DYNDH1588;
26) BIOPSY TRAY, Pack Number DYNDH1693;
27) BIOPSY TRAY, Pack Number DYNDH1693A;
28) LUMBAR PUNCTURE TRAY, Pack Number DYNDH1698;
29) BIOPSY PACK, Pack Number DYNDL1462B;
30) LACERATION TRAY, Pack Number DYNDL1774A;
31) LACERATION TRAY, Pack Number DYNDL1887;
32) CT BIOPSY TRAY W/CHLORAPREP, Pack Number DYNJ05162;
33) LUMBAR EPIDURAL TRAY-LF, Pack Number DYNJRA0313B;
34) BIOPSY TRAY - LF, Pack Number DYNJTS0018A;
35) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214;
36) MYELOGRAM TRAY W/WATER SOLUBLE, Pack Number DYNJTS04035;
37) LUMBAR TRAY, Pack Number DYNJTS0422;
38) MYELOGRAM TRAY, Pack Number DYNJTS0514;
39) INFANT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS07025;
40) ADULT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4301;
41) INFANT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4302;
42) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306;
43) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS8100;
44) CENTRAL LINE INSERTION KIT W/16CM CATH, Pack Number ECVC7440A;
45) OB DELIVERY TRAY, Pack Number MNS10875;
46) OB DELIVERY TRAY, Pack Number MNS10875A;
47) CUSTOM BIOPSY TRAY, Pack Number MNS4815;
48) BIOPSY TRAY, Pack Number P151659;
49) ARTHROGRAM PACK, Pack Number P241108;
50) ARTHROGRAM TRAY, Pack Number SPEC0004C;
51) RADIOLOGY PACK-LF, Pack Number SPEC0127;
52) ARTHROGRAM TRAY, Pack Number SPEC0143A;
53) BIOPSY TRAY, Pack Number SPEC0148;
54) RADIOLOGY/BIOPSY, Pack Number SPEC0149;
55) LUMBAR TRAY, Pack Number SPEC0177;
56) DR COPPEL FACET TRAY, Pack Number SPEC0178A;
57) BIOPSY TRAY W/O LIDOCAINE, Pack Number SPEC0196B;
58) LUMBAR TRAY, Pack Number SPEC0197D;
59) ARTHROGRAM TRAY, Pack Number SPEC0221A;
60) ARTHROGRAM TRAY, Pack Number SPEC0232;
61) 22G FACET TRAY, Pack Number SPEC0265A;
62) LUMBAR PUNCTURE TRAY, Pack Number SPEC0289;
63) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B;
64) ARTHROGRAM TRAY-LF, Pack Number SPEC0400;
65) BIOPSY TRAY-LF, Pack Number SPEC4380;
66) LACERATION TRAY, Pack Number SUT18080;
67) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455;
68) UMBILICAL VESSEL TRAY, Pack Number UVT1100A |
|---|
| Code Information |
DYNDA2063, Lot Number 2021111250;
DYNDA2080, Lot Number 2019052290;
DYNDA2495, Lot Number 2021040550;
DYNDA2497, Lot Number 2022042650;
DYNDH1113, Lot Number 2020022450;
DYNDH1134, Lot Number 2021022250;
DYNDH1137C, Lot Number 2021081990;
DYNDH1257, Lot Number 2019120650;
DYNDH1257, Lot Number 2020060550;
DYNDH1257, Lot Number 2021041550;
DYNDH1270, Lot Number 2019040490;
DYNDH1275, Lot Number 2019022090;
DYNDH1275, Lot Number 2019050990;
DYNDH1275, Lot Number 2019070390;
DYNDH1275, Lot Number 2019081990;
DYNDH1297, Lot Number 2022041250;
DYNDH1300, Lot Number 2020060550;
DYNDH1300, Lot Number 2022041250;
DYNDH1319, Lot Number 2020012750;
DYNDH1321, Lot Number 2019032290;
DYNDH1324B, Lot Number 2022032950;
DYNDH1359, Lot Number 2019040490;
DYNDH1500, Lot Number 2020012750;
DYNDH1500, Lot Number 2022031050;
DYNDH1500, Lot Number 2022032950;
DYNDH1538, Lot Number 2020070850;
DYNDH1539, Lot Number 2020070850;
DYNDH1539, Lot Number 2022042850;
DYNDH1540, Lot Number 2020080750;
DYNDH1540, Lot Number 2020100250;
DYNDH1540A, Lot Number 2020110950;
DYNDH1540A, Lot Number 2021042250;
DYNDH1540A, Lot Number 2021070750;
DYNDH1540A, Lot Number 2021091850;
DYNDH1540A, Lot Number 2023050190;
DYNDH1540A, Lot Number 2023061390;
DYNDH1556B, Lot Number 2022031050;
DYNDH1570, Lot Number 2021041350;
DYNDH1570, Lot Number 2022032450;
DYNDH1574, Lot Number 2022031450;
DYNDH1588, Lot Number 2021021750;
DYNDH1693, Lot Number 2021122050;
DYNDH1693A, Lot Number 2022011150;
DYNDH1698, Lot Number 2022022550;
DYNDH1698, Lot Number 2022031650;
DYNDH1698, Lot Number 2022040550;
DYNDH1698, Lot Number 2022052550;
DYNDH1698, Lot Number 2022060850;
DYNDL1462B, Lot Number 2022042650;
DYNDL1462B, Lot Number 2022050450;
DYNDL1774A, Lot Number 2019040490;
DYNDL1887, Lot Number 2019101890;
DYNJ05162, Lot Number 2020022450;
DYNJRA0313B, Lot Number 2019040490;
DYNJRA0313B, Lot Number 2019053190;
DYNJRA0313B, Lot Number 2019102390;
DYNJTS0018A, Lot Number 2020071050;
DYNJTS0214, Lot Number 2021022250;
DYNJTS04035, Lot Number 2020071050;
DYNJTS0422, Lot Number 2019122750;
DYNJTS0422, Lot Number 2020012350;
DYNJTS0422, Lot Number 2020040850;
DYNJTS0422, Lot Number 2020050850;
DYNJTS0422, Lot Number 2020062550;
DYNJTS0422, Lot Number 2020072350;
DYNJTS0514, Lot Number 2022022250;
DYNJTS07025, Lot Number 2020110450;
DYNJTS07025, Lot Number 2021022250;
DYNJTS07025, Lot Number 2021041550;
DYNJTS07025, Lot Number 2021052450;
DYNJTS07025, Lot Number 2021091850;
DYNJTS07025, Lot Number 2022011150;
DYNJTS07025, Lot Number 2022020750;
DYNJTS07025, Lot Number 2022040650;
DYNJTS4301, Lot Number 2020060550;
DYNJTS4301, Lot Number 2020060550;
DYNJTS4301, Lot Number 2020072250;
DYNJTS4301, Lot Number 2020072250;
DYNJTS4301, Lot Number 2020081950;
DYNJTS4301, Lot Number 2020120450;
DYNJTS4301, Lot Number 2021021750;
DYNJTS4301, Lot Number 2021040550;
DYNJTS4301, Lot Number 2021050250;
DYNJTS4301, Lot Number 2021082550;
DYNJTS4301, Lot Number 2021102250;
DYNJTS4301, Lot Number 2021112250;
DYNJTS4301, Lot Number 2021121750;
DYNJTS4301, Lot Number 2021121750;
DYNJTS4301, Lot Number 2021122050;
DYNJTS4301, Lot Number 2021122050;
DYNJTS4301, Lot Number 2022020350;
DYNJTS4301, Lot Number 2022020350;
DYNJTS4301, Lot Number 2022021850;
DYNJTS4301, Lot Number 2022030250;
DYNJTS4301, Lot Number 2022031450;
DYNJTS4301, Lot Number 2022032450;
DYNJTS4301, Lot Number 2022033050;
DYNJTS4301, Lot Number 2022041250;
DYNJTS4301, Lot Number 2022041350;
DYNJTS4301, Lot Number 2022041350;
DYNJTS4301, Lot Number 2022042650;
DYNJTS4301, Lot Number 2022042550;
DYNJTS4301, Lot Number 2022050450;
DYNJTS4301, Lot Number 2022051850;
DYNJTS4302, Lot Number 2020060850;
DYNJTS4302, Lot Number 2020072250;
DYNJTS4302, Lot Number 2020090250;
DYNJTS4302, Lot Number 2020110250;
DYNJTS4302, Lot Number 2021020950;
DYNJTS4302, Lot Number 2021041350;
DYNJTS4302, Lot Number 2021060150;
DYNJTS4302, Lot Number 2021081950;
DYNJTS4302, Lot Number 2021081950;
DYNJTS4302, Lot Number 2022020250;
DYNJTS4302, Lot Number 2022030650;
DYNJTS4302, Lot Number 2022031450;
DYNJTS4302, Lot Number 2022040650;
DYNJTS4302, Lot Number 2022040650;
DYNJTS4306, Lot Number 2019120650;
DYNJTS4306, Lot Number 2020022450;
DYNJTS4306, Lot Number 2020042250;
DYNJTS4306, Lot Number 2020061150;
DYNJTS4306, Lot Number 2020071050;
DYNJTS4306, Lot Number 2020090250;
DYNJTS4306, Lot Number 2020093050;
DYNJTS4306, Lot Number 2021011950;
DYNJTS4306, Lot Number 2021051350;
DYNJTS4306, Lot Number 2021080650;
DYNJTS4306, Lot Number 2021082750;
DYNJTS4306, Lot Number 2021091850;
DYNJTS4306, Lot Number 2022022250;
DYNJTS8100, Lot Number 2019111450;
DYNJTS8100, Lot Number 2020081850;
DYNJTS8100, Lot Number 2021031750;
DYNJTS8100, Lot Number 2021060250;
DYNJTS8100, Lot Number 2021072750;
DYNJTS8100, Lot Number 2021111250;
DYNJTS8100, Lot Number 2022041850;
ECVC7440A, Lot Number 2022031450;
MNS10875, Lot Number 2019040890;
MNS10875A, Lot Number 2021081990;
MNS4815, Lot Number 2023050190;
P151659, Lot Number 2019102390;
P241108, Lot Number 2020072250;
P241108, Lot Number 2021082550;
P241108, Lot Number 2021111250;
SPEC0004C, Lot Number 2019053190;
SPEC0127, Lot Number 2019111880;
SPEC0143A, Lot Number 2020100250;
SPEC0143A, Lot Number 2021082550;
SPEC0143A, Lot Number 2022011150;
SPEC0148, Lot Number 2022032950;
SPEC0149, Lot Number 2020100250;
SPEC0177, Lot Number 2018121090;
SPEC0177, Lot Number 2019040890;
SPEC0177, Lot Number 2019052290;
SPEC0177, Lot Number 2019091190;
SPEC0177, Lot Number 2019101890;
SPEC0177, Lot Number 2020021390;
SPEC0177, Lot Number 2021081990;
SPEC0177, Lot Number 2021091690;
SPEC0178A, Lot Number 2019040890;
SPEC0178A, Lot Number 2019050990;
SPEC0196B, Lot Number 2019102390;
SPEC0197D, Lot Number 2019111880;
SPEC0197D, Lot Number 2020060180;
SPEC0221A, Lot Number 2020090250;
SPEC0221A, Lot Number 2022033050;
SPEC0232, Lot Number 2021041550;
SPEC0265A, Lot Number 2019101890;
SPEC0289, Lot Number 2019050990;
SPEC0289, Lot Number 2019071690;
SPEC0289, Lot Number 2019092390;
SPEC0289, Lot Number 2019121790;
SPEC0300B, Lot Number 2022033050;
SPEC0400, Lot Number 2020072250;
SPEC4380, Lot Number 2021041550;
SUT18080, Lot Number 2020100250;
SUT18080, Lot Number 2022011150;
SUT20455, Lot Number 2019040490;
UVT1100A, Lot Number 2022020250;
UVT1100A, Lot Number 2022022250 |
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Karin Johnson
886-359-1704 |
|---|
Manufacturer Reason
for Recall | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request these syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods. |
|---|
| Distribution | Worldwide 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.
|
|
|
|
