| | Class 2 Recall
B.Braun Celsite |  |
| Date Posted |
June 27, 2011 |
| Recall Number |
Z-2671-2011 |
| Product |
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 |
| Code Information |
Reference # Model # Lot #
04430425 ST301 J313196U
04430095 ST305V J312177U
04433823 ST301G J313197U
K021193U
04437025 ST501G J312178U
04436725 ST315 J295789U
|
Recalling Firm/
Manufacturer |
B. Braun Interventional Systems
14276 23rd Ave N
Plymouth, Minnesota 55447-4910 |
| Consumer Instructions |
Contact the recalling firm for information |
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
|
| 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 be provided to them by their local BIS Product Specialist.
For additional information contact 800 523-9676 x4459. |
| Quantity in Commerce |
83 |
| Distribution |
NY, ND, OK ,PA |
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