Locking Tear-Away Sheath Introducer Product Line. ACCUGUIDE SINGLE LUMEN 4FR PICC P460K 5/; P560K PICC 5FR W/INTRO KIT;
FDA device recall Z-1062-05 · posted 2005-08-03 · Terminated
Recall details
- Recalling firm
- B. Braun Medical, Inc.
- Reason for recall
- Reports that the tearaway introducer sheaths have cracked hubs/handles and/or improper peeling of the sheath during use.
- Action taken
- Recall letters shere sent out to the firm''s customers on 5/27/2005 via US Mail, Return Receipt Requested.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 11057 cases
- Distribution
- The firm distributed the product to 235 customers both US and International. The international customers are located in Germany, Canada, India, Japan, France, Venezuela, Ireland, and Chile.
- Date initiated
- 2005-05-27
- Date posted
- 2005-08-03
- Date terminated
- 2007-01-03
- Location
- Allentown, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DOUBLE LUMEN PICC (K970926) | B.Braun Medical, Inc. | 1997-08-01 |
| PERIPHERALLY INSERTED CENTRAL CATHETER (K964929) | B.Braun Medical, Inc. | 1997-06-02 |
| ANGEION HEMOSTASIS VALVE INTRODUCER (K894446) | Angeion Corp. | 1989-11-30 |
| CATHETER INTRODUCER (K871153) | Angeion Corp. | 1987-06-24 |
| SIGMA'S CALCIUM PROCEDURE NO. 587 (K871152) | Sigma Diagnostics, Inc. | 1987-06-12 |