Safety

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Cook Medical Expands Global Recall of Select Sizes of Beacon Tip Angiographic Catheters

For Immediate Release

October 9, 2015

Contact

Consumers

Cook Medical Customer Relations
CustomerRelationsNA@cookmedical.com
1-800-457-4500 or 1-812-339- 2235

Media

Marsha Lovejoy, Global Manager, Corporate Content Strategy
marsha.lovejoy@cookmedical.com
812.339.2235 ext. 2750

Announcement

Original Recall

Purpose of the Press Release:

 

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 expansion 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.

Consumers with questions may contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339- 2235, Monday through Friday, between 7:30 a.m. and 5:00 p.m. Eastern time or by email at CustomerRelationsNA@cookmedical.com. Adverse reactions or quality problems experienced with the use

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report online at www.fda.gov/medwatch/report.htm or via regular mail or fax. Download the form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, and then complete and return to the address on the preaddressed form, or submit by fax to 1-800-FDA-0178. Adverse events may also be reported to Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235, Monday through Friday, between 7:30 a.m. and 5:00 p.m. Eastern time or by email at CustomerRelationsNA@cookmedical.com.

Beacon® Tip Angiographic Catheters Recall Extension - Affected Lot Numbers

Beacon® Tip Royal Flush® Plus High-Flow Catheter

Product Catalog Numbers
HNR4.0-35-100-P-10S-0, HNR4.0-35-100-P-10S-CFP, HNR4.0-35-100-P-10S-PIG, HNR4.0-35-100-P-6S-VCF, HNR4.0-35-100-P-NS-0,HNR4.0-35-100-P-NS-DAV, HNR4.0-35-100-P-NS-SIM1, HNR4.0-35-100-P-NS-SIM2, HNR4.0-35-100-ST-10S-0, HNR4.0-35-100-ST-10S-PIG, HNR4.0-35-100-ST-6S-PED, HNR4.0-35-110-P-10S-PIG, HNR4.0-35-120-P-6S-PED,HNR4.0-35-120-ST-6S-PED, HNR4.0-35-125-P-10S-0, HNR4.0-35-125-P-10S-PIG, HNR4.0-35-50-P-NS-0, HNR4.0-35-65-P-8S-VCF,HNR4.0-35-70-P-10S-0, HNR4.0-35-70-P-10S-CFP, HNR4.0-35-70-P-10S-PIG, HNR4.0-35-70-P-4S-PED, HNR4.0-35-70-P-6S-PED,HNR4.0-35-70-P-NS-0, HNR4.0-35-70-ST-10S-0, HNR4.0-35-70-ST-10S-PIG, HNR4.0-35-70-ST-6S-PED, HNR4.0-35-90-P-10S-0,HNR4.0-35-90-P-10S-CFP, HNR4.0-35-90-P-10S-PIG, HNR4.0-35-90-P-6S-PED, HNR4.0-35-90-P-8S-VCF, HNR4.0-35-90-P-NS-0,HNR4.0-35-90-ST-10S-0, HNR4.0-35-90-ST-10S-PIG All Lots

Beacon® Tip Torcon NB® Advantage Catheter

Product Catalog Numbers
HNBR4.0-35-100-P-NS-0, HNBR4.0-35-100-P-NS-C1, HNBR4.0-35-100-P-NS-C2, HNBR4.0-35-100-P-NS-CANADA-041480, HNBR4.0-35-100-P-NS-DAV, HNBR4.0-35-100-P-NS-H1, HNBR4.0-35-100-P-NS-JB1, HNBR4.0-35-100-P-NS-JB2,HNBR4.0-35-100-P-NS-JB3, HNBR4.0-35-100-P-NS-JIM, HNBR4.0-35-100-P-NS-KMP, HNBR4.0-35-100-P-NS-MPA,HNBR4.0-35-100-P-NS-O1, HNBR4.0-35-100-P-NS-SIM1, HNBR4.0-35-100-P-NS-SIM2, HNBR4.0-35-100-P-NS-SIM3,HNBR4.0-35-100-P-NS-VERT, HNBR4.0-35-100-P-NS-VTK, HNBR4.0-35-100-P-NS-WNBG, HNBR4.0-35-125-P-NS-0,HNBR4.0-35-125-P-NS-DAV, HNBR4.0-35-125-P-NS-H1, HNBR4.0-35-125-P-NS-JB1, HNBR4.0-35-125-P-NS-JB2,HNBR4.0-35-125-P-NS-MPA, HNBR4.0-35-125-P-NS-SIM2, HNBR4.0-35-125-P-NS-VERT, HNBR4.0-35-125-P-NS-VTK,HNBR4.0-35-125-P-NS-WNBG, HNBR4.0-35-40-P-NS-KMP, HNBR4.0-35-65-P-NS-0, HNBR4.0-35-65-P-NS-C1,HNBR4.0-35-65-P-NS-C2, HNBR4.0-35-65-P-NS-C3, HNBR4.0-35-65-P-NS-DAV, HNBR4.0-35-65-P-NS-H1, HNBR4.0-35-65-P-NS-JB1,HNBR4.0-35-65-P-NS-KMP, HNBR4.0-35-65-P-NS-MPA, HNBR4.0-35-65-P-NS-RC1, HNBR4.0-35-65-P-NS-RC2,HNBR4.0-35-65-P-NS-RDC, HNBR4.0-35-65-P-NS-RIM, HNBR4.0-35-65-P-NS-SIM1, HNBR4.0-35-65-P-NS-SIM2,HNBR4.0-35-80-P-NS-C1, HNBR4.0-35-80-P-NS-C2, HNBR4.0-35-80-P-NS-JL2, HNBR4.0-35-80-P-NS-JL2.5,HNBR4.0-35-80-P-NS-JL3, HNBR4.0-35-80-P-NS-JR1, HNBR4.0-35-80-P-NS-JR2, HNBR4.0-35-80-P-NS-JR3.5,HNBR4.0-35-80-P-NS-RH, HNBR4.0-35-80-P-NS-RLG, HNBR4.0-35-80-P-NS-VS, HNBR4.0-35-80-P-NS-VS1,HNBR4.0-35-80-P-NS-VS2, HNBR4.0-35-80-P-NS-VS3, HNBR4.0-NT-100-P-NS-H1, HNBR4.0-NT-80-P-NS-RC1,HNBR4.0-NT-80-P-NS-RIM, HNBR4.0-NT-80-P-NS-RLG, HNBR4.1-35-100-P-NS-0, HNBR4.1-35-100-P-NS-C1,HNBR4.1-35-100-P-NS-C2, HNBR4.1-35-100-P-NS-DAV, HNBR4.1-35-100-P-NS-H1, HNBR4.1-35-100-P-NS-JB1,HNBR4.1-35-100-P-NS-JB2, HNBR4.1-35-100-P-NS-JB3, HNBR4.1-35-100-P-NS-KMP, HNBR4.1-35-100-P-NS-MPA,HNBR4.1-35-100-P-NS-O1, HNBR4.1-35-100-P-NS-SIM1, HNBR4.1-35-100-P-NS-SIM2, HNBR4.1-35-100-P-NS-SIM3,HNBR4.1-35-100-P-NS-VERT, HNBR4.1-35-100-P-NS-WNBG, HNBR4.1-35-110-P-NS-JB1, HNBR4.1-35-110-P-NS-JB2,HNBR4.1-35-110-P-NS-WNBG, HNBR4.1-35-120-P-NS-JB2, HNBR4.1-35-130-P-NS-DAV-T, HNBR4.1-35-40-P-NS-KMP,HNBR4.1-35-65-P-NS-C1, HNBR4.1-35-65-P-NS-C2, HNBR4.1-35-65-P-NS-DAV, HNBR4.1-35-65-P-NS-H1, HNBR4.1-35-65-P-NS-JB1,HNBR4.1-35-65-P-NS-KMP, HNBR4.1-35-65-P-NS-LEV1, HNBR4.1-35-65-P-NS-MPA, HNBR4.1-35-65-P-NS-RC1,HNBR4.1-35-65-P-NS-RC2, HNBR4.1-35-65-P-NS-RDC, HNBR4.1-35-65-P-NS-RIM, HNBR4.1-35-65-P-NS-SHK1.0,HNBR4.1-35-65-P-NS-SIM1, HNBR4.1-35-75-P-NS-CHG-D, HNBR4.1-35-80-P-NS-C1, HNBR4.1-35-80-P-NS-C2,HNBR4.1-35-80-P-NS-JL2, HNBR4.1-35-80-P-NS-JL2.5, HNBR4.1-35-80-P-NS-JL3, HNBR4.1-35-80-P-NS-JR1,HNBR4.1-35-80-P-NS-JR2, HNBR4.1-35-80-P-NS-JR3.5, HNBR4.1-35-80-P-NS-RC1, HNBR4.1-35-80-P-NS-RH,HNBR4.1-35-80-P-NS-RLG, HNBR4.1-35-80-P-NS-VS, HNBR4.1-35-80-P-NS-VS2, HNBR4.1-NT-100-P-NS-H1,HNBR4.1-NT-80-P-NS-C1, HNBR4.1-NT-80-P-NS-RC1, HNBR4.1-NT-80-P-NS-RH, HNBR4.1-NT-80-P-NS-RIM,HNBR4.1-NT-80-P-NS-RLG, HNBR5.0-35-65-P-NS-RUC, HNBR5.0-35-90-P-NS-RUC All Lots

Shuttle® Select Slip-Cath® Catheter

Product Catalog Numbers
SCBR4.5-35-135-P-NS-ANG-SHTL, SCBR4.5-35-135-P-NS-ANG-SHTL-JP, SCBR4.5-35-150-P-NS-0-SHTL,SCBR4.5-35-150-P-NS-ANG-SHTL,SCBR4.5-35-75-P-NS-ANG-SHTL, SCBR5.0-35-90-P-NS-RUC All Lots

Slip-Cath® Beacon® Tip Catheter

Product Catalog Numbers
SCBR4.0-35-150-P-NS-0, SCBR4.0-35-65-P-NS-RC2, SCBR4.0-38-100-P-NS-0, SCBR4.0-38-100-P-NS-C2, SCBR4.0-38-100-P-NS-AV,SCBR4.0-38-100-P-NS-H1, SCBR4.0-38-100-P-NS-HN4, SCBR4.0-38-100-P-NS-JB1, SCBR4.0-38-100-P-NS-JB2,SCBR4.0-38-100-P-NS-KMP, SCBR4.0-38-100-P-NS-MAN, SCBR4.0-38-100-P-NS-MPA, SCBR4.0-38-100-P-NS-MPB,SCBR4.0-38-100-P-NS-SIM1, SCBR4.0-38-100-P-NS-SIM2, SCBR4.0-38-100-P-NS-SIM3, SCBR4.0-38-100-P-NS-VERT,SCBR4.0-38-125-P-NS-0, SCBR4.0-38-125-P-NS-DAV, SCBR4.0-38-125-P-NS-JB1, SCBR4.0-38-125-P-NS-SIM1,SCBR4.0-38-125-P-NS-SIM2, SCBR4.0-38-125-P-NS-TEGT, SCBR4.0-38-125-P-NS-VERT, SCBR4.0-38-125-P-NS-VTK,SCBR4.0-38-40-P-NS-KMP, SCBR4.0-38-65-P-NS-0, SCBR4.0-38-65-P-NS-C2, SCBR4.0-38-65-P-NS-KMP, SCBR4.0-38-65-P-NS-MPA,SCBR4.0-38-65-P-NS-RIM, SCBR4.0-38-65-P-NS-TC, SCBR4.0-38-65-P-NS-TC-BNK, SCBR4.0-38-65-P-NS-VERT,SCBR4.0-38-80-P-NS-RH, SCBR4.0-38-80-P-NS-VS, SCBR4.0-38-80-P-NS-VS1, SCBR4.0-38-80-P-NS-VS2, SCBR4.0-38-80-P-NS-VS3,SCBR4.1-35-65-P-NS-C2, SCBR4.1-35-75-P-NS-CHG2.5 All Lots

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