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U.S. Department of Health and Human Services

Class 2 Device Recall ClearPro TPiece Closed Suction Catheter

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 Class 2 Device Recall ClearPro TPiece Closed Suction Cathetersee related information
Date Initiated by FirmJune 30, 2020
Create DateJuly 28, 2020
Recall Status1 Open3, Classified
Recall NumberZ-2724-2020
Recall Event ID 85983
Product Classification Catheters, suction, tracheobronchial - Product Code BSY
ProductClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.
Code Information Model: DYNCPTP14, Lot #6919020016:
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries Inc
Three Lakes Drive
Northfield IL 60093
For Additional Information ContactKassandra Cotner
866-359-1704
Manufacturer Reason
for Recall		There are reports of the suction catheter coming apart from the device assembly during use.
FDA Determined
Cause 2		Process control
ActionCustomer letter dated 06/29/2020 was issued to consignees. Consignees are asked to check their inventory for impacted product and destroy affected product. Consignees are asked to complete and return a destruction form listing quantity of affected product destroyed or indicate no product was on hand. Additionally, if product has been further distributed, consignees are asked to notify those customers who may be impacted.
Quantity in Commerce2440 units
DistributionUS Nationwide distribution including in the states of AR, AZ, CA, FL, GA, IL, MS, NY, NV, OH, PA, TX.
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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