Bronchial Double Lumen Tube Set (Left), Sterile
FDA device recall Z-2407-2015 · posted 2015-08-18 · Terminated
Recall details
- Recalling firm
- Teleflex, Inc.
- Reason for recall
- Customer complaints reporting that the cobb connector detached from the main connector prior to use.
- Action taken
- Recall letters were sent on 11/21/2014 to consignees requesting them to discontinue use and quarantine the products. The letter includes a reply form to be returned. The letter to the distributors requested a sub-recall, and included a recall letter to be sent to their accounts.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTS
- Quantity affected
- 6,991 ea. - US & 136,759 ea. - INTL
- Distribution
- AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV. WI, DC, Puerto Rico, Canada, Bolivia, Ecuador, Hong
- Date initiated
- 2014-11-21
- Date posted
- 2015-08-18
- Date terminated
- 2017-08-15
- Location
- Wayne, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RUSCH ENDOBRONCHIAL TUBE SETS (K951091) | Rusch Intl. | 1995-06-08 |