| Class 2 Device Recall Medline |  |
Date Initiated by Firm | September 04, 2024 |
Date Posted | October 23, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0156-2025 |
Recall Event ID |
95415 |
Product Classification |
Cardiovascular procedure kit - Product Code OEZ
|
Product | Medline brand, medical procedure convenience kits, labeled as:
a) CUH OPEN HEART A B C - CDS, REF CDS983202I;
a) PICC INSERTION KIT, REF DYNDC2486A;
a) OPEN HEART PACK, REF DYNJ01201L;
a) BREAST/CHEST SHEET PACK-LF, REF DYNJ0537343G;
a) COTTON ROLL KIT-LF, REF DYNJ32727A;
a) VASCULAR PACK-LF, REF DYNJ32915B;
a) SUAREZ AVR/MVR PACK, REF DYNJ35884C;
a) VALVE ACCESSORY PACK, REF DYNJ36241K;
a) ENSEMBLE ABDO-PERINEAL-LF, REF DYNJ38084B;
a) EP PACK, REF DYNJ40488;
a) PACEMAKER PACK SMGH-LF, REF DYNJ41925G;
a) PACEMAKER TEGH-LF, REF DYNJ46745A;
a) VEIN AND LASER PACK, REF DYNJ49874;
a) DR NACKMAN VEIN PACK, REF DYNJ56235;
a) NEUROVASCULAR PACK, REF DYNJ66718A;
a) VEIN TRAY, REF DYNJ69012C;
a) LOOP RECORDER-LF, REF DYNJ69196;
a) U BAR DRAPE, REF DYNJ80064;
a) ENDO, REF DYNJ903814B;
a) CARDIAC PROCEDURE, REF DYNJ908126;
a) CARDIAC PROCEDURE, REF DYNJ908126;
a) VASCULAR EXTREMITY PACK, REF SYNJ10322A;
a) VASCULAR EXTREMITY, REF SYNJ910026A |
Code Information |
a) REF CDS983202I, UDI/DI 40195327164677 (each), 10195327164676 (case), Lot Numbers: 23LBI662;
b) REF DYNDC2486A, UDI/DI 40889942648055 (each). 10889942648054 (case), Lot Numbers: 23LBM830;
c) REF DYNJ01201L, UDI/DI 40888277744807 (each), 10888277744806 (case), Lot Numbers: 23LBP126;
d) REF DYNJ0537343G, UDI/DI 40193489517072 (each), 10193489517071 (case), Lot Numbers: 23LBP442;
e) REF DYNJ32727A, UDI/DI 40888277036346 (each), 10888277036345 (case), Lot Numbers: 24ABB296;
f) REF DYNJ32915B, UDI/DI 40195327486427 (each), 10195327486426 (case), Lot Numbers: 23LBK382;
g) REF DYNJ35884C, UDI/DI 40195327547609 (each), 10195327547608 (case), Lot Numbers: 24ABF463;
h) REF DYNJ36241K, UDI/DI 40195327555949 (each), 10195327555948 (case), Lot Numbers: 23LBL339;
i) REF DYNJ38084B, UDI/DI 40889942670841 (each), 10889942670840 (case), Lot Numbers: 23LBR317;
j) REF DYNJ40488, UDI/DI 40884389861685 (each), 10884389861684 (case), Lot Numbers: 23LBL628;
k) REF DYNJ41925G, UDI/DI 40193489677349 (each), 10193489677348 (case), Lot Numbers: 24ABA421;
l) REF DYNJ46745A, UDI/DI 40889942279297 (each), 10889942279296 (case), Lot Numbers: 23KBB860;
m) REF DYNJ49874, UDI/DI 40888277890603 (each), 10888277890602 (case), Lot Numbers: 23LBL699;
n) REF DYNJ56235, UDI/DI 40889942621553 (each), 10889942621552 (case), Lot Numbers: 23EBD843A;
o) REF DYNJ66718A, UDI/DI 40193489916332 (each), 10193489916331 (case), Lot Numbers: 24ABN915;
p) REF DYNJ69012C, UDI/DI 40195327515943 (each), 10195327515942 (case), Lot Numbers: 23LBQ949;
q) REF DYNJ69196, UDI/DI 40193489906234 (each), 10193489906233 (case), Lot Numbers: 23LBR843;
r) REF DYNJ80064, UDI/DI 40195327009251 (each), 10195327009250 (case), Lot Numbers: 23LBP174;
s) REF DYNJ903814B, UDI/DI 40195327333769 (each), 10195327333768 (case), Lot Numbers: 23LBS865;
t) REF DYNJ908126, UDI/DI 40193489980111 (each), 10193489980110 (case), Lot Numbers: 24BBA256;
u) REF DYNJ908126, UDI/DI 40193489374378 (each), 10193489374377 (case), Lot Numbers: 24ABN040;
v) REF SYNJ10322A, UDI/DI 40193489374378 (each), 10193489374377 (case), Lot Numbers: 24ABD377;
w) REF SYNJ910026A, UDI/DI 40193489374491 (each), 10193489374490 (case), Lot Numbers: 24ABV352 |
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 | 2631 units |
Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Panama. |
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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