Recall Z-1857-2022 ยท BSY Catheters, Suction, Tracheobronchial
MEDLINE INDUSTRIES, LP - Northfield
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
| Date | Sep 29, 2022 (initiated Aug 3, 2022) |
| Status | Open, Classified |
| Reason | 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 | Under Investigation by firm |
| Action | 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. |
| 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, Pa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.