Codman & Shurtleff, Inc.: Sterility of device may be compromised due to lack of packaging integrity; Sterility of device may be compromised due to lack of package integrity

Agency Publication Date: February 20, 2013

Affected Products

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Product: 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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 64158

Status: Resolved

Manufacturer: Codman & Shurtleff, Inc.

Manufactured In: United States

Units Affected: 24 products (867 units; 19 units; 56 units; 50 units; 234 units; 867 units; 273 units; 266 units; 32 units; 34 units; 129 units; 5 units; 5 units; 202 units; 1548 units; 202 units; 46 units; 46 units; 268 units; 141 units; 10 units; 64 units; 25; 522 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

All unexpired lots

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 64158

Status: Resolved

Manufacturer: Codman & Shurtleff, Inc.

Manufactured In: United States