—#182375

Product

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 product code: BSY — Catheters, Suction, Tracheobronchial
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: Model: DYNCPTP14T, Lot #6918100021:

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: Three Lakes Drive, Northfield, Illinois 60093

Distribution

Distribution pattern: US Nationwide distribution including in the states of AR, AZ, CA, FL, GA, IL, MS, NY, NV, OH, PA, TX.

Timeline

Recall initiated: 2020-06-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182375. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.