Recall Z-1062-05 ยท DYB Introducer, Catheter
B. Braun Medical, Inc.
Locking Tear-Away Sheath Introducer Product Line. ACCUGUIDE SINGLE LUMEN 4FR PICC P460K 5/; P560K PICC 5FR W/INTRO KIT; MTI451845 4.5FR MINI T/A; MTI551845 5.5FR MINI TA; MTI651845 6.5FR MINI T/A; P460OTW SNGL LUM PICC W/MTI; P4552K DBL LUM PICC INTRO KIT; P5552K DBL LUM PICC INTRO KIT; P4552KOTW DBL LUM OTW PICC INTRO KIT LF; LOCKING T/A INTRODUCERS 11FR; INTRADYN TEAR-AWAY INTRODUCER 4F; INTRA
| Date | Aug 3, 2005 (initiated May 27, 2005) |
| Status | Terminated |
| Reason | Reports that the tearaway introducer sheaths have cracked hubs/handles and/or improper peeling of the sheath during use. |
| Root cause | Other |
| Action | Recall letters shere sent out to the firm''s customers on 5/27/2005 via US Mail, Return Receipt Requested. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K871152 | SIGMA'S CALCIUM PROCEDURE NO. 587 Sigma Diagnostics, Inc., Jun 12, 1987 |
| K871153 | CATHETER INTRODUCER Angeion Corp., Jun 24, 1987 |
| K894446 | ANGEION HEMOSTASIS VALVE INTRODUCER Angeion Corp., Nov 30, 1989 |
| K964929 | PERIPHERALLY INSERTED CENTRAL CATHETER B.Braun Medical, Inc., Jun 2, 1997 |
| K970926 | DOUBLE LUMEN PICC B.Braun Medical, Inc., Aug 1, 1997 |