FDAClass IIOctober 5, 2022

Medline Clearpro Trach T-piece Closed Suction Catheter recall

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…

Why was Medline Clearpro Trach T-piece Closed Suction Catheter recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

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…
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
136,080 units
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
Recall date
October 5, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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