B. Braun Celsite Venous Access Ports , Distributed by Aesculpa Inc. Model ST301, ST305V, ST301G, ST501G and ST315 Refere

FDA device recall Z-2671-2011 · posted 2011-06-27 · Terminated

Recall details

Recalling firm

B. Braun Interventional Systems

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 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.

Root cause

Process design

Status

Terminated

Product code

LJT

Quantity affected

83

Distribution

NY, ND, OK ,PA

Date initiated

2011-04-13

Date posted

2011-06-27

Date terminated

2012-07-06

Location

Plymouth, MN

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