MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. TRACH DOUBLE SWIVEL, 12 Fr, Item Number/REF: DYNCPDS12T b. TRACH DOUBLE SWIVEL, 14 Fr, Item Number/REF: DYNCPDS14T
Check against the official notice below — it lists the full affected range.
Medline Industries is recalling 34,920 units of ClearPro Trach Double Swivel Closed Suction Catheters due to a defect where the suction catheter may separate from the green connector near the thumb valve during the patient suctioning process when the catheter is pulled out of an artificial airway. The affected product was distributed nationwide across all U.S. states and Puerto Rico, as well as internationally to Canada, Chile, Colombia, Panama, Qatar, and the United Arab Emirates.
The recalled catheters are identified by specific lot numbers and UDI codes listed in the recall notice. The source document does not specify a remedy or instructions for what affected consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential for the suction catheter to come apart from the green connector near the thumb valve. The connector is coming apart from the assembled device when pulling the catheter out of the artificial airway in the patient suctioning process.
Reason for recall: Potential for the suction catheter to come apart from the green connector near the thumb valve. The connector is coming apart from the assembled device when pulling the catheter out of the artificial airway in the patient suctioning process. Distribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico. International distribution to Canada, Chile, Colombia, Panama, Qatar, United Arab Emirates Quantity: 34,920 units Lot/code info: a. UDI-DI (GTIN) case: (01)20888277703374; UDI-DI (GTIN) Each: (01)10888277703377, Lot Numbers 6921090011, 6922030011; b. UDI-DI (GTIN) case: (01)20888277703398; UDI-DI (GTIN) Each: (01)10888277703391, Lot Numbers 6921040012, 6921070011, 6921080011, 6921100011, 6921120011, 6921120021, 6922030011, 6922040011
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.