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U.S. Department of Health and Human Services

Enforcement Report - Week of February 27, 2013

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Event Detail

Event ID 64158
Product Type Devices
Status Ongoing
Recalling Firm Codman & Shurtleff, Inc.
City Raynham
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-11
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of package integrity 522 units Z-0865-2013
NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of package integrity 25 Z-0864-2013
NEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of package integrity 64 units Z-0863-2013
NEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of package integrity 10 units Z-0862-2013
NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of package integrity 141 units Z-0861-2013
NEUROPATH 6Fx90 GUIDING CATH ST Product Code: GST60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of package integrity 268 units Z-0860-2013
NEUROPATH 5Fx90 GUIDING CATH ST Product Code: GST50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of package integrity 46 units Z-0859-2013
NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of package integrity 46 units Z-0858-2013
NEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of package integrity 202 units Z-0857-2013
NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of package integrity 1548 units Z-0856-2013
NEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of package integrity 202 units Z-0855-2013
NEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of package integrity 5 units Z-0854-2013
NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of package integrity 5 units Z-0853-2013
NEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of package integrity 129 units Z-0852-2013
NEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of package integrity 34 units Z-0851-2013
NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of package integrity 32 units Z-0850-2013
NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of package integrity 266 units Z-0849-2013
NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of package integrity 273 units Z-0848-2013
NEUROPATH 6Fx100 GUIDING CATH MPD Product Code: GMD60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of package integrity 867 units Z-0847-2013
NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GMC51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of package integrity 234 units Z-0846-2013
NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of package integrity 50 units Z-0845-2013
NEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of package integrity 56 units Z-0844-2013
NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of package integrity 19 units Z-0843-2013
NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices All unexpired lots Class II Sterility of device may be compromised due to lack of packaging integrity 867 units Z-0842-2013
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