Recall Z-1132-2019 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Wilson-Cook Medical Inc.
Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.
| Date | Jan 4, 2019 |
| Status | Terminated |
| Reason | Complaints of the snare loop not completely retracting and/or misshaping of the snare loop. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Cook Medical, sent an"URGENT: MEDICAL DEVICE RECALL" letter to its customers. The letter described the product, problem and actions to be taken. The customer were instructed to do the following: 1. Review the labels of impacted product shipped to your account and quarantine any affected product that remains unused. If you are a distributor and the products have been distributed, contact your customer(s) and direct them to quarantine any affected product. 2. Immediately collect and return all unused affected products at one time to Cook Medical as soon as possible. Affected product s |
| Quantity | 34,456 units |
| Distribution | Worldwide Distribution: US (nationwide) in the states of: AL, AR, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and countries of: ARGENTINA, BRAZIL, CANADA, MEXICO, NETHERLANDS ANTILLES, AUSTRI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K851958 | ROTATABLE POLYPECTOMY SNARE POS-1 Wilson-Cook Medical, Inc., Jul 25, 1985 |