Cook Medical Expands Global Recall of Select Sizes of Beacon Tip Angiographic Catheters
BLOOMINGTON, Ind., On
October 7, 2015, Cook Medical initiated a voluntary recall for select sizes of
Beacon® Tip Angiographic Catheters. This recall includes all
lots of these select sizes of the Beacon® Tip Angiographic
Catheters. This recall is an extension of the voluntary lot-specific recall
issued on July 2, 2015. The products include specific versions of the Torcon NB® Advantage
Beacon® Tip Catheters (catalog prefix HNBR4.0, HNBR4.1 and only
HNBR5.0 with the RUC suffix), Royal Flush® Plus Beacon® Tip
High-Flow Catheters (catalog prefix HNR4.0), and Slip-Cath® Beacon® Tip
Hydrophilic Catheters (catalog prefix SCBR4.0, SCBR4.1, and only SCBR5.0 with
the RUC suffix), and Shuttle® Select Slip-Cath® catheters
(catalog prefix SCBR4.5).
The Beacon Tip Angiographic Catheters have been found to exhibit tip splitting or separation, which has resulted in 42 Medical Device Reports. Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or, if not retrieved, has the potential to occlude blood flow to end organs.
The Beacon Tip Angiographic Catheters in this recall were distributed globally between September 2012 and September 2015. Product can be identified by the part number provided on the outer package product label. The part numbers for products subject to this recall are those with catalog number prefixes and suffixes listed in the initial paragraph above. All lots currently in distribution are affected.
Cook Medical has notified its customers and distributors by recall notification letters. The letters requested that all customers and distributors quarantine and discontinue use of all potentially affected units and return the affected product to the company as soon as possible for credit.
The FDA and other regulatory agencies around the world have been notified of this action.
Source: Cook Medical
Comments