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Terminated

ClearPro 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.

FDA Recall Z-0058-2021 · Posted None

Recalling FirmMedline Industries Inc
Recall StatusTerminated
Product CodeBSY
Date Initiated2020-09-01
Date Terminated2022-05-27
Product Quantity6225 units

Reason for Recall

There have been reports of the suction catheter coming apart from the device assembly during use.

Firm Action

Medline 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.

Root Cause

Process control

Distribution Pattern

62 US consignees; 1 government consignee, 4 foreign consignees

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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