Recall Z-1521-2018 ยท DQY Catheter, Percutaneous
Cook Inc.
Advance 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0; UDI: 10827002522647 and 10827002522524 Product Usage: The Advance 35LP Low Profile PTA Balloon Dilation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofem
| Date | Apr 16, 2018 |
| Status | Terminated |
| Reason | Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa. |
| Root cause | Labeling mix-ups |
| Action | On April 16, 2018 Cook Medical Inc. mailed an Urgent Medical Device recall notification to affected customers. Customers were instructed to: 1) Examine your inventory immediately to determine if you have affected product(s), and quarantine affected product(s). Immediately cease all distribution and use of these products; 2) Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. NOTE: Unaffected products that are returned will not be credited; 3) Please complete the Acknowledgement and Receipt Form within 5 business days |
| Quantity | 40 total products |
| Distribution | Worldwide Distribution - US Nationwide in the states of AZ, DE, FL, GA, ID, IL, KY, MI, MO, NH, NJ, PA, RI, TX, UT and the country of Peru |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091527 | ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER Cook, Inc., Jun 12, 2009 |