Katzen" Infusion Wire, 0.035 in x 180 cm, UPN Product No. M001461930, RED Catalog No. 46-193, Made in USA 8600. Boston S
FDA device recall Z-3053-2011 · posted 2011-08-23 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 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.
- Date initiated
- 2011-08-01
- Date posted
- 2011-08-23
- Date terminated
- 2012-08-10
- Location
- Maple Grove, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KATZEN THROMBOLYSIS GUIDEWIRE (K883880) | Medi-Tech, Inc. | 1989-04-06 |