Recalls / —
—#52950
Product
Thermodilution Right Heart Catheters, Catalog Numbers 604028 and 604165. The product is shipped 5 units per carton.-B. Braun Medical, Allentown, Pa.
- FDA product code
- DYG — Catheter, Flow Directed
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K832287
- Affected lot / code info
- Catalog numbers 604028: Lot numbers 60759210 exp 6/07, 60774338 exp 9/07, 60774339 exp 6/07, 60789198 exp 7/07, 60793228 exp 8/07, 60798079 exp 6/07, 60798080 exp 7/07, 60798858 exp 8/07, 60805581 exp 8/07, 60814631 exp 10/07, 60814632 exp 9/07, 60816722 exp 10/07, 60873702 exp 7/08, 60885381 exp 10/08, 60887358 exp 9/08, 60894377 exp 11/08, 60899729 exp 11/08, 60906657 exp 12/08, 60911647 exp 1/09, and 60916540 exp 3/09. --Catalog numbers 60416540: Lot numbers 60781356 exp 7/07 and 60798862
Why it was recalled
Cracks at the Catheter Tip
Root cause (FDA determination)
Other
Action the firm took
On 6/5/07, a Product Removal Notice was issued to the only distributor that received the product in Japan
Recalling firm
- Firm
- B. Braun Medical, Inc.
- Address
- 901 Marcon Boulevard, Allentown, Pennsylvania 18109-9512
Distribution
- Distribution pattern
- International ONLY- Japan
Timeline
- Recall initiated
- 2007-06-05
- Posted by FDA
- 2007-07-23
- Terminated
- 2007-10-31
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #52950. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.