| Class 2 Device Recall Medline |  |
Date Initiated by Firm | September 04, 2024 |
Date Posted | October 23, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0157-2025 |
Recall Event ID |
95415 |
Product Classification |
Central venous catheter tray - Product Code OFF
|
Product | Medline brand medical procedure convenience kits, labeled as:
a) KIT LINE INSERTION, REF CVI4730A;
b) KIT LINE INSERTION, REF CVI4730A;
c) LINE INSERTION TRAY, REF DYNJ20803D;
d) CENTRAL LINE PACK-LF, REF DYNJ28368;
e) CENTRAL LINE PACK-LF, REF DYNJ28368;
f) PICC PACK-LF, REF DYNJ28487;
g) PICC PACK-LF, REF DYNJ28487H;
h) CENTRAL LINE PACK, REF DYNJ30087C;
i) CENTRAL LINE ADULT PACK, REF DYNJ35352;
j) PICC PACK, REF DYNJ52255;
k) PICC PROCEDURE PACK, REF DYNJ59067A;
l) PICC PROCEDURE PACK, REF DYNJ59067A;
m) DR SIRAGUSA VEIN PACK, REF DYNJ61247A;
n) PICC TEAM PACK, REF DYNJ64542A;
o) PICC LINE INSERTION PACK, REF DYNJ65519;
p) CVL INSERTION KIT II PGYBK, REF DYNJ68112;
q) CVL INSERTION KIT II PGYBK, REF DYNJ68112;
r) PICC PACK, REF DYNJ69088A;
s) PICC INSERTION TRAY, REF DYNJ80031;
t) ENDOVENOUS ABLATION PACK, REF DYNJ80489A;
u) CVR ENDOVENOUS PACK, REF DYNJ80643;
v) RADIAL ARTERY PACK, REF DYNJ83938; |
Code Information |
a) REF CVI4730A, UDI/DI 40195327562039 (each), 10195327562038 (case), Lot Numbers: 24ABK903;
b) REF CVI4730A, UDI/DI 40195327562039 (each), 10195327562038 (case), Lot Numbers: 23LBN351;
c) REF DYNJ20803D, UDI/DI 40889942553885 (each), 10889942553884 (case), Lot Numbers: 24ABE939;
d) REF DYNJ28368, UDI/DI 40080196200161 (each), 10080196200160 (case), Lot Numbers: 24ABD995;
e) REF DYNJ28368, UDI/DI UDI/DI 40080196200161 (each), 10080196200160 (case), Lot Numbers: 23KBE939;
f) REF DYNJ28487, UDI/DI 40080196227021 (each), 10080196227020 (case), Lot Numbers: 24ABI626;
g) REF DYNJ28487H, UDI/DI40080196227021 (each), 10080196227020 (case), Lot Numbers: 24ABI626;
h) REF DYNJ30087C, UDI/DI 40889942754145 (each), 10889942754144 (case), Lot Numbers: 23JBS113;
i) REF DYNJ35352, UDI/DI 40884389433080 (each), 10884389433089 (case), Lot Numbers: 23LBN154;
j) REF DYNJ52255, UDI/DI 40889942253709 (each), 10889942253708 (case), Lot Numbers: 24ABC063;
k) REF DYNJ59067A, UDI/DI 40195327421282 (each), 10195327421281 (case), Lot Numbers: 24ABC903;
l) REF DYNJ59067A, UDI/DI 40195327421282 (each), 10195327421281 (case), Lot Numbers: 23LBM072;
m) REF DYNJ61247A, UDI/DI 40195327492862 (each), 10195327492861 (case), Lot Numbers: 23LBN198;
n) REF DYNJ64542A, UDI/DI 40193489293723 (each), 0193489293722 (case), Lot Numbers: 23LBN027;
o) REF DYNJ65519, UDI/DI 40193489283939 (each), 10193489283938 (case), Lot Numbers: 24ABE345;
p) REF DYNJ68112, UDI/DI 40193489498906 (each), 10193489498905 (case), Lot Numbers: 24ABH428;
q) REF DYNJ68112, UDI/DI 40193489498906 (each), 10193489498905 (case), Lot Numbers: 23LBT018;
r) REF DYNJ69088A, UDI/DI 40193489975247 (each), 10193489975246 (case), Lot Numbers: 23LBP745;
s) REF DYNJ80031, UDI/DI 40195327007745 (each), 10195327007744 (case), Lot Numbers: 23LBN003;
t) REF DYNJ80489A, UDI/DI 40195327582723 (each), 10195327582722 (case), Lot Numbers: 23LBP033;
u) REF DYNJ80643, UDI/DI 40195327055791 (each), 10195327055790 (case), Lot Numbers: 23KBK131;
v) REF DYNJ83938, UDI/DI 40195327317233 (each), 101953273172329 (case), Lot Numbers: 24ABG864
|
Recalling Firm/ Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield 3 Lakes Dr Northfield IL 60093-2753
|
For Additional Information Contact | Karin Johnson 866-359-1704 |
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. |
FDA Determined Cause 2 | Under Investigation by firm |
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. |
Quantity in Commerce | 5238 units |
Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Panama. |
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.
|
|
|
|