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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64158

24 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 11, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Codman & Shurtleff, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

24 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 24

NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0842-2013
Recall number
Z-0842-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
867 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of packaging integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of packaging integrity

Code information

All unexpired lots

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.

device · product 2 of 24

NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0843-2013
Recall number
Z-0843-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
19 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of package integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of package integrity

Code information

All unexpired lots

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.

device · product 3 of 24

NEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0844-2013
Recall number
Z-0844-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
56 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of package integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of package integrity

Code information

All unexpired lots

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.

device · product 4 of 24

NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0845-2013
Recall number
Z-0845-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of package integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of package integrity

Code information

All unexpired lots

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.

device · product 5 of 24

NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GMC51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0846-2013
Recall number
Z-0846-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
234 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of package integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of package integrity

Code information

All unexpired lots

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.

device · product 6 of 24

NEUROPATH 6Fx100 GUIDING CATH MPD Product Code: GMD60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0847-2013
Recall number
Z-0847-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
867 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of package integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of package integrity

Code information

All unexpired lots

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.

device · product 7 of 24

NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0848-2013
Recall number
Z-0848-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
273 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of package integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of package integrity

Code information

All unexpired lots

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.

device · product 8 of 24

NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0849-2013
Recall number
Z-0849-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
266 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of package integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of package integrity

Code information

All unexpired lots

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.

device · product 9 of 24

NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0850-2013
Recall number
Z-0850-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
32 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of package integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of package integrity

Code information

All unexpired lots

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.

device · product 10 of 24

NEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0851-2013
Recall number
Z-0851-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
34 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of package integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of package integrity

Code information

All unexpired lots

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.

device · product 11 of 24

NEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0852-2013
Recall number
Z-0852-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
129 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of package integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of package integrity

Code information

All unexpired lots

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.

device · product 12 of 24

NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0853-2013
Recall number
Z-0853-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of package integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of package integrity

Code information

All unexpired lots

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.

device · product 13 of 24

NEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0854-2013
Recall number
Z-0854-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of package integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of package integrity

Code information

All unexpired lots

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.

device · product 14 of 24

NEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0855-2013
Recall number
Z-0855-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
202 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of package integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of package integrity

Code information

All unexpired lots

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.

device · product 15 of 24

NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0856-2013
Recall number
Z-0856-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
1548 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of package integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of package integrity

Code information

All unexpired lots

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.

device · product 16 of 24

NEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0857-2013
Recall number
Z-0857-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
202 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of package integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of package integrity

Code information

All unexpired lots

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.

device · product 17 of 24

NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0858-2013
Recall number
Z-0858-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
46 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of package integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of package integrity

Code information

All unexpired lots

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.

device · product 18 of 24

NEUROPATH 5Fx90 GUIDING CATH ST Product Code: GST50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0859-2013
Recall number
Z-0859-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
46 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of package integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of package integrity

Code information

All unexpired lots

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.

device · product 19 of 24

NEUROPATH 6Fx90 GUIDING CATH ST Product Code: GST60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0860-2013
Recall number
Z-0860-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
268 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of package integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of package integrity

Code information

All unexpired lots

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.

device · product 20 of 24

NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0861-2013
Recall number
Z-0861-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
141 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of package integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of package integrity

Code information

All unexpired lots

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.

device · product 21 of 24

NEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0862-2013
Recall number
Z-0862-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of package integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of package integrity

Code information

All unexpired lots

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.

device · product 22 of 24

NEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0863-2013
Recall number
Z-0863-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
64 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of package integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of package integrity

Code information

All unexpired lots

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.

device · product 23 of 24

NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0864-2013
Recall number
Z-0864-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
25

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of package integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of package integrity

Code information

All unexpired lots

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.

device · product 24 of 24

NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

Z-0865-2013
Recall number
Z-0865-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
522 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterility of device may be compromised due to lack of package integrity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility of device may be compromised due to lack of package integrity

Code information

All unexpired lots

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.