| Class 2 Device Recall Medline Convenience kits | |
Date Initiated by Firm | June 06, 2022 |
Create Date | July 27, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1470-2022 |
Recall Event ID |
90516 |
Product Classification |
Cardiovascular procedure kit - Product Code OEZ
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Product | Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number DYNJ902880J, c. VASCULAR CDS, Model Number DYNJ902880K, d. OPEN HEART A & B, Model Number DYNJ904831F, e. OPEN HEART MHS, Model Number DYNJ905394A, f. OPEN HEART MHS, Model Number DYNJ905394B, g. OPEN HEART WPH, Model Number DYNJ908168
Model/Catalog Number: Model Numbers: a. CDS984642, b. DYNJ902880J, c. DYNJ902880K, d. DYNJ904831F, e. DYNJ905394A, f. DYNJ905394B, g. DYNJ908168
Product Description: convenience kits labeled as follows: |
Code Information |
a. Model Number CDS984642, Lot codes: 19JBB553
b. Model Number DYNJ902880J, Lot codes: 21FBR331, 21HBD394, 21IBP835, 21KBM214, 21DBE158
c. Model Number DYNJ902880K, Lot codes: 22BBD964, 21KBV788, 21LBN478
e. Model Number DYNJ904831F, Lot codes: 22DBT300, 22DBU172, 22BBO313, 21JBX260, 21KBO308
f. Model Number DYNJ905394A, Lot codes: 21HBJ840, 21IBU071, 21JBY922, 21DBS569, 21FBA011
g. Model Number DYNJ905394B, Lot codes: 22ABM646
h. Model Number DYNJ908168, Lot codes: 22EBB265
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Recalling Firm/ Manufacturer |
MEDLINE INDUSTRIES, LP - SPT 1170 S Northpoint Blvd Waukegan IL 60085-6757
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For Additional Information Contact | Kassandra Cotner 866-775-6072 |
Manufacturer Reason for Recall | Kits contain leaking bottles of isopropyl alcohol |
FDA Determined Cause 2 | Under Investigation by firm |
Action | The firm's consignees were notified by US mail on 06/06/2022 and instructed to destroy any affected kits on hand in accordance with their local and state regulations. |
Quantity in Commerce | 1960 |
Distribution | US Nationwide distribution. |
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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