MEDLINE CLEARPRO 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. ET LENGTH DOUBLE SWIVEL, 12 Fr, Item Number/REF: DYNCPDS12; b. ET LENGTH DOUBLE SWIVEL, 14 Fr, Item Number/REF: DYNCPDS14; c. ET LENGTH
Check against the official notice below — it lists the full affected range.
Medline Industries is recalling 65,320 units of ClearPro Double Swivel Closed Suction Catheters distributed nationwide and internationally. The recalled devices have a potential defect where the suction catheter may separate from the green connector near the thumb valve during the patient suctioning process, specifically when the catheter is being withdrawn from an artificial airway.
The affected products were distributed across all 50 U.S. states, Washington D.C., Puerto Rico, and internationally to Canada, Chile, Colombia, Panama, Qatar, and the United Arab Emirates. The specific lot numbers and product codes are identified in the recall notice. The source document does not specify a remedy or corrective action for affected consumers.
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: 65,320 units Lot/code info: a. UDI-DI (GTIN) case: (01)20888277703367; UDI-DI (GTIN) Each: (01)10888277703360, Lot Number 6922040021; b. UDI-DI (GTIN) case: (01)20888277703381; UDI-DI (GTIN) Each: (01)10888277703384, Lot Numbers 6921050011, 6921070011, 6921070021, 6921060011, 6921060021, 6921080011, 6921100011, 6921100021, 6921120011, 6922010011, 6922020021, 6922030011; c. UDI-DI (GTIN) case: (01)20888277703404; UDI-DI (GTIN) Each: (01)10888277703407, Lot Number 6921120021
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.