MEDLINE INDUSTRIES, LP - Northfield: 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.

Agency Publication Date: September 29, 2022

Affected Products

Product: 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 DOUBLE SWIVEL, 16 Fr, Item Number/REF: DYNCPDS16

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

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Product: 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

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

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Product: 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

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.

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90722

Status: Active

Manufacturer: MEDLINE INDUSTRIES, LP - Northfield

Manufactured In: United States

Units Affected: 3 products (65,320 units; 34,920 units; 136,080 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

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