MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner c

FDA device recall Z-1855-2022 · posted 2022-09-29 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

BSY

Quantity affected

65,320 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, V

Date initiated

2022-08-03

Date posted

2022-09-29

Location

Northfield, IL