—#40231

Product

Right Heart Catheter Product Line: Catalog Number 601276 ----WP1107 Wedge Press Cath.

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: 601276. Lot Number, Exp. Date: 0060447424, 4/30/05; 0060449287, 4/30/05; 0060460591, 5/31/05; 0060461660, 6/30/05; 0060479198, 7/31/05; 0060485764, 8/31/05; 0060499554, 9/30/05; 0060503596, 10/31/05; 0060510910, 10/31/05; 0060534551, 12/31/05; 0060542987, 1/31/06; 0060551093, 2/28/06; 0060558251, 2/28/06; 0060563877, 3/31/06; 0060568298, 4/30/06; 0060577421, 4/30/06; 0060704964, 6/30/06; 0060707117, 8/31/06; 0060709910, 7/31/06; 0060720394, 9/30/06; 0060724488, 9/30/06; 0060724492, 10/31/06; 0060730638, 11/30/06; 0060733105, 11/30/06; 0060735054, 11/30/06; 0060741469, 12/31/06; 0060743202, 1/31/06.

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 #40231. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.