Recalls / —
—#40239
Product
Right Heart Catheter Product Line: Catalog Number 604100-----------T147-03 A427D1014 KANI 25PP.
- FDA product code
- DYG — Catheter, Flow Directed
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K822806, K832287, K841639
- Affected lot / code info
- Catalog Number 604100. Lot Number, Exp.Date: 0060708624, 7/31/06; 0060720757, 8/31/06.
Why it was recalled
Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
Root cause (FDA determination)
Other
Action the firm took
The firm sent out recall notification letters to the Directors of Materials Management on 5/27/2005.
Recalling firm
- Firm
- B. Braun Medical, Inc.
- Address
- 901 Marcon Blvd, Allentown, Pennsylvania 18109-9512
Distribution
- Distribution pattern
- Product was distributed to distributors and hospitals nationwide. Also, the products were distributed to Germany and Japan.
Timeline
- Recall initiated
- 2005-05-25
- Posted by FDA
- 2005-07-16
- Terminated
- 2006-12-14
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #40239. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.