| Class 2 Device Recall Medline |  |
Date Initiated by Firm | September 04, 2024 |
Date Posted | October 23, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0155-2025 |
Recall Event ID |
95415 |
Product Classification |
Cardiac catheterization kit - Product Code OES
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Product | Medline brand, medical procedure convenience kits, labeled as:
a) RADIOLOGY LP TRAY, REF DYNDH1609;
b) CARDIAC CATH PACK-LF, REF DYNJ19010I;
c) SUPPLEMENTAL NEURO ANGIO PK, REF DYNJ29207;
d) ANGIO PACK, REF DYNJ43661C;
e) LEFT HEART CATH TEGH-LF, REF DYNJ46746C;
f) LFT HRT CATH RADIAL ACCESS-LF, REF DYNJ47667C;
g) IR ARM PACK, REF DYNJ50712D;
h) IR PACK, REF DYNJ67324;
i) PL. CATHETERISME CARDIAQUE, REF HCT093J |
Code Information |
a) REF DYNDH1609: UDI/DI 40193489844802 (each), 10193489844801 (case), Lot Numbers: 23LBO852;
b) REF DYNJ19010I: UDI/DI 40888277858627 (each), 10888277858626 (case), Lot Numbers: 23LBK443;
c) REF DYNJ29207: UDI/DI 40080196015413 (each), 10080196015412 (case), Lot Numbers: 23LBL962;
d) REF DYNJ43661C: UDI/DI 40195327104353 (each), 10195327104351 (case), Lot Numbers: 23LBU931;
e) REF DYNJ46746C: UDI/DI 40195327040162 (each), 10195327040161 (case), Lot Numbers: 23LBK374;
f) REF DYNJ47667C: UDI/DI 40195327040179 (each), 10195327040178 (case), Lot Numbers: 23LBL629;
g) REF DYNJ50712D: UDI/DI 40195327267927 (each), 10195327267926 (case), Lot Numbers: 23KBE846;
h) REF DYNJ67324: UDI/DI 40193489395625 (each), 10193489395624 (case), Lot Numbers: 23LBL780;
i) REF HCT093J: UDI/DI 40884389905679 (each), 10884389905678 (case), Lot Numbers: 23LBG513
|
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 | 1460 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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