—#195608

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

FDA product code: BSY — Catheters, Suction, Tracheobronchial
Device class: Class 1
Medical specialty: Anesthesiology
Affected 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

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On about 08/03/2022, Medline notified consignees via first class mail letter of the recall. The letter instructed consignees to immediately review inventory and destroy all affected product and complete the response form indicated at the link provided in the letter. Distributors were instructed to notify customers if further distributed, instruct those customers destroy any affected product, and include customer quantities on response form.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2022-08-03
Posted by FDA: 2022-09-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #195608. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.