Recall Z-2671-2011 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
B. Braun Interventional Systems
B. Braun Celsite Venous Access Ports , Distributed by Aesculpa Inc. Model ST301, ST305V, ST301G, ST501G and ST315 Reference # Model # 04430425 ST301 04430095 ST305V 04433823 ST301G 04437025 ST501G 04436725 ST315
| Date | Jun 27, 2011 (initiated Apr 13, 2011) |
| Status | Terminated |
| Reason | The affected products contain the incorrect winged Surecan needle accessory component in certain Celsite Access Port package configurations. The winged Surecan needle is used to deliver medications and fluids into implanted Celsite Access Ports. Two winged Surecan needle sizes are provided in Celsite U.S. package configurations: 20G (PN 4058631) or 22G (PN 16006593A). A 20G or 22G needle |
| Root cause | Process design |
| Action | B.Braun Interventional Systems Inc, (BIS) sent a "Urgent Medical Device Recall" letter on April 16, 2011 to all affected customers. The letter described the problem and the product involved in the recall. Informed consignees that their local B.Braun Interventional System Inc Product Specialists will contact them with the specifics for return/replacement of the product upon return of qualified removed product. They also requested that a Celsite Access Port Patient Implant Form be filled out for each patient implanted with one of the Celsite Access Ports from the affected lots. This Form to b |
| Quantity | 83 |
| Distribution | NY, ND, OK ,PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061424 | CELSITE/ CELSITE CONCEPT, ACCESS PORTS Aesculap, Inc., Jul 31, 2006 |
| K952548 | CELSITE VENOUS SYSTEM B.Braun Medical, Inc., Jul 21, 1995 |
| K962230 | CELSITE PORT WITH PRECONNECTED CATHETER B.Braun Medical, Inc., Dec 16, 1996 |
| K993024 | CELSITE IMPLANTABLE PORT WITH VALVED CATHETER B. Braun of America, Inc., Mar 13, 2000 |