Portex Tracheal Tube Guide 15 Fr, non-sterile Catalog Number: 153013
FDA device recall Z-0572-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc
- Reason for recall
- Tracheal tube guide mislabeled as a 15 Fr instead of a 10 Fr
- Action taken
- Smiths Medical notified consignees by letter dated 1/26/04 by FedEx. Customers are requested to inspect their inventory for the size. Incorrectly labeled product is to be returned for credit or replacement. Customers and dealers are directed to fax back the attached Reply Letter.
- Root cause
- Other
- Status
- Terminated
- Product code
- BSR
- Quantity affected
- 46 cases (230 UNITS)
- Distribution
- CA, CO, FL, GA, IN, MA, MD, MI. NH, NC, NY, TX, WA
- Date initiated
- 2004-01-26
- Date posted
- 2004-07-20
- Date terminated
- 2012-05-08
- Location
- Keene, NH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRACHEAL TUBE STYLET (K902180) | Sims Surgical, Inc. | 1990-07-19 |