Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use only. Indicated for use in patients re
FDA device recall Z-1913-2009 · posted 2009-08-25 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences, Llc
- Reason for recall
- Edwards LifeSciences LLC received several complaints, in which the blue connector of the introducer assembly has broken (fracture/separation) after several hours of use.
- Action taken
- Edwards LifeSciences LLC initiated the worldwide recall via customer letters dated May 11, 2009 and are being sent by Federal Express stating that customers cease using affected product from the indicated lots and return all unused products. The firm requested that the customer provide written verification of stock and identify any unused product to be returned. For further information, contact Edwards LifeSciences LLC Customer Service at 1-800-424-3278.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 67,357 Units
- Distribution
- Worldwide Distribution: United States (AL, AR, CA, CO, CT, DC, FL, GA, IA, IL, IN,KS, KY, MA, MD, ME, MI, MO, MS, ND, NH, NJ, NM, NV, NY, OH, PA, RI, SC, TN, TX, VA, WV, HI and PR), Austria, Canada, S
- Date initiated
- 2009-05-11
- Date posted
- 2009-08-25
- Date terminated
- 2012-02-23
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BAXTER HEMOSTASIS VALVE INTRODUCERS (K981909) | Baxter Edwards | 1998-11-24 |