Recall Z-2725-2020 ยท BSY Catheters, Suction, Tracheobronchial
Medline Industries Inc
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.
| Date | Jun 30, 2020 |
| Status | Open, Classified |
| Reason | There are reports of the suction catheter coming apart from the device assembly during use. |
| Root cause | Process control |
| 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. |
| Quantity | 680 units |
| Distribution | US Nationwide distribution including in the states of AR, AZ, CA, FL, GA, IL, MS, NY, NV, OH, PA, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.