| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | April 08, 2024 |
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| Date Posted | September 06, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-3027-2024 |
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| Recall Event ID |
94583 |
| Product Classification |
Dressing change tray - Product Code OXQ
|
| Product | Medline Convenience kits labeled as:
1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C;
2) CHEST TUBE INSERTION TRAY, Pack Number CHT1900;
3) CHEST TUBE INSERTION TRAY, Pack Number CHT560;
4) CHEST TUBE INSERTION TRAY, Pack Number CHT705;
5) PORT TRAY , Pack Number DT19245;
6) BIOPSY KIT, Pack Number DYNDA1466A;
7) BIOPSY KIT, Pack Number DYNDA1466A;
8) CATH REMOVAL, Pack Number DYNDA1733B;
9) CATH REMOVAL, Pack Number DYNDA1814;
10) CATH REMOVAL, Pack Number DYNDA1814;
11) CATH REMOVAL, Pack Number DYNDA1814;
12) CATH REMOVAL, Pack Number DYNDA1814;
13) CATH REMOVAL, Pack Number DYNDA1814;
14) CATH REMOVAL, Pack Number DYNDA1814;
15) CATH REMOVAL, Pack Number DYNDA1814;
16) CATH REMOVAL, Pack Number DYNDA1814;
17) SHUNT TRAY, Pack Number DYNDA2725;
18) PORT ACCESS KIT, Pack Number DYNDC2945;
19) PORT ACCESS KIT, Pack Number DYNDC2945;
20) PORT ACCESS KIT, Pack Number DYNDC2945;
21) PORT ACCESS KIT, Pack Number DYNDC2945;
22) PORT ACCESS KIT, Pack Number DYNDC2945;
23) PORT ACCESS KIT, Pack Number DYNDC2945;
24) PORT ACCESS KIT, Pack Number DYNDC2945;
25) PORT ACCESS KIT, Pack Number DYNDC2945;
26) PORT ACCESS KIT, Pack Number DYNDC2945;
27) PORT ACCESS KIT, Pack Number DYNDC2945;
28) ARTHROGRAM TRAY, Pack Number DYNDH1113;
29) BIOPSY TRAY, Pack Number DYNDH1137C;
30) BIOPSY PACK, Pack Number DYNDH1248;
31) DIAGNOSTIC TRAY, Pack Number DYNDH1359;
32) MYELOGRAM TRAY, Pack Number DYNDH1531;
33) BIOPSY PACK, Pack Number DYNDL1462B;
34) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B;
35) PORT DRSG KIT W/CHG GEL, Pack Number EBSI1039B;
36) PORT ACCESS TRAY, Pack Number EBSI1241;
37) PORT ACCESS TRAY, Pack Number EBSI1241;
38) PORT ACCESS TRAY, Pack Number EBSI1241;
39) PORT ACCESS TRAY, Pack Number EBSI1241;
40) PORT ACCESS TRAY, Pack Number EBSI1241;
41) PORT ACCESS TRAY, Pack Number EBSI1241;
42) PORT ACCESS TRAY, Pack Number EBSI1241;
43) PORT ACCESS TRAY, Pack Number EBSI1241;
44) PORT ACCESS TRAY, Pack Number EBSI1241;
45) PORT ACCESS TRAY, Pack Number EBSI1241;
46) PORT ACCESS TRAY, Pack Number EBSI1241;
47) PORT ACCESS TRAY, Pack Number EBSI1241;
48) PORT ACCESS TRAY, Pack Number EBSI1241;
49) PORT ACCESS TRAY, Pack Number EBSI1241;
50) PORT ACCESS TRAY, Pack Number EBSI1241;
51) PORT ACCESS TRAY, Pack Number EBSI1241;
52) PORT ACCESS TRAY, Pack Number EBSI1241;
53) PORT ACCESS TRAY, Pack Number EBSI1241;
54) DIALYSIS CHANGE KIT, Pack Number EBSI1453;
55) DIALYSIS CHANGE KIT, Pack Number EBSI1453;
56) DIALYSIS CHANGE KIT, Pack Number EBSI1453A;
57) DIALYSIS CHANGE KIT, Pack Number EBSI1453A;
58) OB DELIVERY TRAY, Pack Number MNS10875A;
59) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150;
60) OB DELIVERY SET, Pack Number MNS3355;
61) LUMBAR TRAY, Pack Number SPEC0177;
62) 22G FACET TRAY, Pack Number SPEC0265A;
63) FINE LACERATION KIT, Pack Number SUT19360;
64) LACERATION TRAY, Pack Number SUT20955;
65) LACERATION TRAY, Pack Number SUT3780;
66) LACERATION TRAY, Pack Number SUT3780;
67) SUTURING SET, Pack Number SUT4020 |
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| Code Information |
ART245C, Lot Number 2023083090;
CHT1900, Lot Number 2020092590;
CHT560, Lot Number 2020110590;
CHT705, Lot Number 2023011790;
DT19245 , Lot Number 21JBN311 ;
DYNDA1466A, Lot Number 2021111090;
DYNDA1466A, Lot Number 2023091890;
DYNDA1733B, Lot Number 2019021950;
DYNDA1814, Lot Number 2018103050;
DYNDA1814, Lot Number 2018121450;
DYNDA1814, Lot Number 2019010950;
DYNDA1814, Lot Number 2019021950;
DYNDA1814, Lot Number 2019041850;
DYNDA1814, Lot Number 2019112250;
DYNDA1814, Lot Number 2020031350;
DYNDA1814, Lot Number 2020100801;
DYNDA2725, Lot Number 2023011790;
DYNDC2945, Lot Number 2020071090;
DYNDC2945, Lot Number 2020090990;
DYNDC2945, Lot Number 2020110590;
DYNDC2945, Lot Number 2020122890;
DYNDC2945, Lot Number 2021081890;
DYNDC2945, Lot Number 2021120890;
DYNDC2945, Lot Number 2022121290;
DYNDC2945, Lot Number 2023011090;
DYNDC2945, Lot Number 2023080790;
DYNDC2945, Lot Number 2023091890;
DYNDH1113, Lot Number 2020031350;
DYNDH1137C, Lot Number 2021011890;
DYNDH1248, Lot Number 2019021950;
DYNDH1359, Lot Number 2023080790;
DYNDH1531, Lot Number 2022020990;
DYNDL1462B, Lot Number 2019010950;
EBSI1039B, Lot Number 2023083090;
EBSI1039B, Lot Number 2023110390;
EBSI1241, Lot Number 2019120590;
EBSI1241, Lot Number 2020040390;
EBSI1241, Lot Number 2020061990;
EBSI1241, Lot Number 2020092590;
EBSI1241, Lot Number 2020111390;
EBSI1241, Lot Number 2021011890;
EBSI1241, Lot Number 2021041290;
EBSI1241, Lot Number 2021091590;
EBSI1241, Lot Number 2021111090;
EBSI1241, Lot Number 2021120690;
EBSI1241, Lot Number 2022020990;
EBSI1241, Lot Number 2022042290;
EBSI1241, Lot Number 2022072690;
EBSI1241, Lot Number 2022082990;
EBSI1241, Lot Number 2022101390;
EBSI1241, Lot Number 2023011790;
EBSI1241, Lot Number 2023090690;
EBSI1241, Lot Number 2023110390;
EBSI1453, Lot Number 2022022180;
EBSI1453, Lot Number 2022032880;
EBSI1453A, Lot Number 2022093090;
EBSI1453A, Lot Number 2023083090;
MNS10875A, Lot Number 2023011790;
MNS12150, Lot Number 2022121290;
MNS3355, Lot Number 2020071090;
SPEC0177, Lot Number 2019120590;
SPEC0265A, Lot Number 2019120590;
SUT19360, Lot Number 2022042290;
SUT20955, Lot Number 2020092590;
SUT3780, Lot Number 2020061990;
SUT3780, Lot Number 2020111390;
SUT4020, Lot Number 2023091890 |
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Karin Johnson
886-359-1704 |
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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. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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. |
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| Distribution | Worldwide distribution. |
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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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