ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.
FDA Recall Z-2725-2020 · Posted None
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Recalling FirmMedline Industries Inc
Recall StatusOpen, Classified
Product CodeBSY
Date Initiated2020-06-30
Product Quantity680 units
Reason for Recall
There are reports of the suction catheter coming apart from the device assembly during use.
Firm Action
Customer 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.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution including in the states of AR, AZ, CA, FL, GA, IL, MS, NY, NV, OH, PA, TX.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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