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
This recall has been terminated (originally issued June 27, 2011).
- Company
- B. Braun Interventional Systems
- Recall Initiated
- April 13, 2011
- Posted
- June 27, 2011
- Terminated
- July 6, 2012
- Recall Number
- Z-2671-2011
- Quantity
- 83
- Firm Location
- Plymouth, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
NY, ND, OK ,PA
Lot / Code Info
Reference # Model # Lot # 04430425 ST301 J313196U 04430095 ST305V J312177U 04433823 ST301G J313197U K021193U 04437025 ST501G J312178U 04436725 ST315 J295789U
Root Cause
Process design
Action Taken
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 be provided to them by their local BIS Product Specialist. For additional information contact 800 523-9676 x4459.