Recall Z-3053-2011 ยท DQX Wire, Guide, Catheter
Boston Scientific Corporation
Katzen" Infusion Wire, 0.035 in x 180 cm, UPN Product No. M001461930, RED Catalog No. 46-193, Made in USA 8600. Boston Scientific. NW 41 Street, Miami, FL 33166. Intended for the infusion of therapeutic agents (i.e., heparin, saline, thrombolytic agents, etc) in the peripheral vasculature. The wire allows for the delivery of agents in either a "pulse -spray" or " slow weep" technique.
| Date | Aug 23, 2011 (initiated Aug 1, 2011) |
| Status | Terminated |
| Reason | Boston Scientific is voluntarily recalling one lot/batch of Katzen" Infusion Wires because we have identified that the label on the carton and the inner pouch indicated an incorrect device length. The labels indicate a device length of 180cm while the actual device length is 145cm. |
| Root cause | Labeling mix-ups |
| Action | Boston Scientific sent an "Urgent Medical Device Recall Removal" letter dated August 1, 2011 to all affected customers. The letter described the problem and product being recalled and advised customers to segregate the affected product immediately and return it to Boston Scientific. Boston Scientific requested the completion and return of the Reply Verification Tracking Form. For additional information on this recall call Boston Scientific Quality Systems at (763) 494-1133. |
| Quantity | 33 |
| Distribution | (USA) Nationwide distribution including the states of AZ, AR, CA, CO, FL, GA, IL, IN, NV, NY, NC, OH, PA, RI, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K883880 | KATZEN THROMBOLYSIS GUIDEWIRE Medi-Tech, Inc., Apr 6, 1989 |