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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Convenience kits

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 Class 2 Device Recall Medline Convenience kitssee related information
Date Initiated by FirmJune 06, 2022
Create DateJuly 27, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1470-2022
Recall Event ID 90516
Product Classification Cardiovascular procedure kit - Product Code OEZ
ProductMedline 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
Recalling Firm/
Manufacturer
MEDLINE INDUSTRIES, LP - SPT
1170 S Northpoint Blvd
Waukegan IL 60085-6757
For Additional Information ContactKassandra Cotner
866-775-6072
Manufacturer Reason
for Recall
Kits contain leaking bottles of isopropyl alcohol
FDA Determined
Cause 2
Under Investigation by firm
ActionThe 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 Commerce1960
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC 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.
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