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U.S. Department of Health and Human Services

Class 2 Device Recall ClearPro Closed Suction Catheter

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 Class 2 Device Recall ClearPro Closed Suction Cathetersee related information
Date Initiated by FirmSeptember 01, 2020
Create DateOctober 06, 2020
Recall Status1 Terminated 3 on May 27, 2022
Recall NumberZ-0058-2021
Recall Event ID 86423
Product Classification Catheters, suction, tracheobronchial - Product Code BSY
ProductClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.
Code Information Model: DYNCPDS14T, Lots 06919010016 and 06919020016
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries Inc
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactKassandra Cotner
866-359-1704
Manufacturer Reason
for Recall		There have been reports of the suction catheter coming apart from the device assembly during use.
FDA Determined
Cause 2		Process control
ActionMedline Industries, Inc. sent formal letters with response forms to each consignee affected via first class mail on 09/01/2020. Customers are asked to perform subrecalls as necessary. Consignees are asked to complete a response form a return via fax or email. Each response received will be recorded and subsequent letters will be initiated to non-responders. Recalled product at the consignee site should be destroyed at the consignee location per their local and state regulations. The recalling firm is not asking for product to be returned.
Quantity in Commerce6225 units
Distribution62 US consignees; 1 government consignee, 4 foreign consignees
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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