MEDLINE CLEARPRO TRACH T-PIECE 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 T-PIECE, 14 Fr, Item Number/REF: DYNCPTP14; b. TRACH T-PIECE, 14 Fr, Item Number/REF: DYNCPTP14T
Check against the official notice below — it lists the full affected range.
Medline Industries is recalling 136,080 units of ClearPro Trach T-Piece Closed Suction Catheters due to a defect where the suction catheter can come apart from the green connector near the thumb valve during the patient suctioning process, specifically when pulling the catheter out of the artificial airway. The affected products were 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 devices are identified by specific lot numbers and UDI codes listed in the recall notice. Consumers with affected units can identify them by checking the lot numbers and UDI-DI (GTIN) codes on their products. The recall record does not specify a remedy or instructions for what affected consumers should do.
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: 136,080 units Lot/code info: a. UDI-DI (GTIN) case: (01)20888277703466; UDI-DI (GTIN) Each: (01)10888277703469, Lot Numbers 6922030011; b. UDI-DI (GTIN) case: (01)20888277703473; UDI-DI (GTIN) Each: (01)10888277703476, Lot Numbers 6921050011, 6921060011, 6921040012, 6921110011, 6921120011 6921120012, 6922010011, 6922010012, 6922010031, 6922020031, 6922030011.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.