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.
This recall is currently active, issued June 30, 2020. It was issued by Medline Industries Inc.
- Company
- Medline Industries Inc
- Recall Initiated
- June 30, 2020
- Recall Number
- Z-2725-2020
- Quantity
- 680 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
There are reports of the suction catheter coming apart from the device assembly during use.
Distribution
US Nationwide distribution including in the states of AR, AZ, CA, FL, GA, IL, MS, NY, NV, OH, PA, TX.
Lot / Code Info
Model: DYNCPTP14T, Lot #6918100021:
Root Cause
Process control
Action Taken
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.