Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.

Class I - Dangerous

🏥 Medical Devices Recalled: April 15, 2016 Cook Diagnostic Equipment Nationwide

What Should You Do?

Check if you have this product:
All Lots. Catalog prefixes SCBR5.0, SCBR5.5, and SCBR6.5 Catalog/product number; Global/order number SCBR5.0-38-100-P-NS-0 G12005 SCBR5.0-38-100-P-NS-C2 G12008 SCBR5.0-38-100-P-NS-DAV G11996 SCBR5.0-38-100-P-NS-H1 G11991 SCBR5.0-38-100-P-NS-HN4 G23693 SCBR5.0-38-100-P-NS-JB1 G11997 SCBR5.0-38-100-P-NS-JB2 G11998 SCBR5.0-38-100-P-NS-KMP G28535 SCBR5.0-38-100-P-NS-MAN G11999 SCBR5.0-38-100-P-NS-MPA G12002 SCBR5.0-38-100-P-NS-NTR G23695 SCBR5.0-38-100-P-NS-RVC G43120 SCBR5.0-38-100-P-NS-SIM1 G12000 SCBR5.0-38-100-P-NS-SIM2 G11992 SCBR5.0-38-100-P-NS-SIM3 G12001 SCBR5.0-38-100-P-NS-TEGT G23694 SCBR5.0-38-100-P-NS-VERT G12007 SCBR5.0-38-100-P-NS-VTK G13163 SCBR5.0-38-125-P-NS-0 G32366 SCBR5.0-38-125-P-NS-DAV G13413 SCBR5.0-38-125-P-NS-H1 G23696 SCBR5.0-38-125-P-NS-JB1 G13530 SCBR5.0-38-125-P-NS-SIM1 G32369 SCBR5.0-38-125-P-NS-SIM2 G13200 SCBR5.0-38-125-P-NS-TEGT G32367 SCBR5.0-38-125-P-NS-VERT G12168 SCBR5.0-38-125-P-NS-VTK G12082 SCBR5.0-38-40-P-NS-KMP G11993 SCBR5.0-38-65-P-NS-0 G12009 SCBR5.0-38-65-P-NS-C1 G12003 SCBR5.0-38-65-P-NS-C2 G11994 SCBR5.0-38-65-P-NS-C3 G12004 SCBR5.0-38-65-P-NS-DAV G23688 SCBR5.0-38-65-P-NS-H1 G13319 SCBR5.0-38-65-P-NS-KMP G12156 SCBR5.0-38-65-P-NS-LEV1 G12798 SCBR5.0-38-65-P-NS-MPA G23689 SCBR5.0-38-65-P-NS-RC2 G13272 SCBR5.0-38-65-P-NS-RDC G13092 SCBR5.0-38-65-P-NS-RIM G11995 SCBR5.0-38-65-P-NS-SIM1 G12716 SCBR5.0-38-65-P-NS-SIM2 G23691 SCBR5.0-38-65-P-NS-TC G36320 SCBR5.0-38-65-P-NS-TC-BNK G36322 SCBR5.0-38-65-P-NS-TEGT G12179 SCBR5.0-38-80-P-NS-C2 G12006 SCBR5.0-38-80-P-NS-MPA G23692 SCBR5.0-38-80-P-NS-RH G36214 SCBR5.0-38-80-P-NS-VS G13431 SCBR5.0-38-80-P-NS-VS1 G13432 SCBR5.0-38-80-P-NS-VS2 G13433 SCBR5.0-38-80-P-NS-VS3 G13434 SCBR5.5-35-60-P-NS-PATEL G51570 SCBR6.5-35-60-P-NS-PATEL G51571
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Cook Inc.
Reason for Recall:: Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.

Product Codes/Lot Numbers:

All Lots. Catalog prefixes SCBR5.0, SCBR5.5, and SCBR6.5 Catalog/product number; Global/order number SCBR5.0-38-100-P-NS-0 G12005 SCBR5.0-38-100-P-NS-C2 G12008 SCBR5.0-38-100-P-NS-DAV G11996 SCBR5.0-38-100-P-NS-H1 G11991 SCBR5.0-38-100-P-NS-HN4 G23693 SCBR5.0-38-100-P-NS-JB1 G11997 SCBR5.0-38-100-P-NS-JB2 G11998 SCBR5.0-38-100-P-NS-KMP G28535 SCBR5.0-38-100-P-NS-MAN G11999 SCBR5.0-38-100-P-NS-MPA G12002 SCBR5.0-38-100-P-NS-NTR G23695 SCBR5.0-38-100-P-NS-RVC G43120 SCBR5.0-38-100-P-NS-SIM1 G12000 SCBR5.0-38-100-P-NS-SIM2 G11992 SCBR5.0-38-100-P-NS-SIM3 G12001 SCBR5.0-38-100-P-NS-TEGT G23694 SCBR5.0-38-100-P-NS-VERT G12007 SCBR5.0-38-100-P-NS-VTK G13163 SCBR5.0-38-125-P-NS-0 G32366 SCBR5.0-38-125-P-NS-DAV G13413 SCBR5.0-38-125-P-NS-H1 G23696 SCBR5.0-38-125-P-NS-JB1 G13530 SCBR5.0-38-125-P-NS-SIM1 G32369 SCBR5.0-38-125-P-NS-SIM2 G13200 SCBR5.0-38-125-P-NS-TEGT G32367 SCBR5.0-38-125-P-NS-VERT G12168 SCBR5.0-38-125-P-NS-VTK G12082 SCBR5.0-38-40-P-NS-KMP G11993 SCBR5.0-38-65-P-NS-0 G12009 SCBR5.0-38-65-P-NS-C1 G12003 SCBR5.0-38-65-P-NS-C2 G11994 SCBR5.0-38-65-P-NS-C3 G12004 SCBR5.0-38-65-P-NS-DAV G23688 SCBR5.0-38-65-P-NS-H1 G13319 SCBR5.0-38-65-P-NS-KMP G12156 SCBR5.0-38-65-P-NS-LEV1 G12798 SCBR5.0-38-65-P-NS-MPA G23689 SCBR5.0-38-65-P-NS-RC2 G13272 SCBR5.0-38-65-P-NS-RDC G13092 SCBR5.0-38-65-P-NS-RIM G11995 SCBR5.0-38-65-P-NS-SIM1 G12716 SCBR5.0-38-65-P-NS-SIM2 G23691 SCBR5.0-38-65-P-NS-TC G36320 SCBR5.0-38-65-P-NS-TC-BNK G36322 SCBR5.0-38-65-P-NS-TEGT G12179 SCBR5.0-38-80-P-NS-C2 G12006 SCBR5.0-38-80-P-NS-MPA G23692 SCBR5.0-38-80-P-NS-RH G36214 SCBR5.0-38-80-P-NS-VS G13431 SCBR5.0-38-80-P-NS-VS1 G13432 SCBR5.0-38-80-P-NS-VS2 G13433 SCBR5.0-38-80-P-NS-VS3 G13434 SCBR5.5-35-60-P-NS-PATEL G51570 SCBR6.5-35-60-P-NS-PATEL G51571

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2614-2016

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