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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65420

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

Open FDA event record

Event summary

Timeline bucket
June 07, 2013
Product types
Device
Classifications
Class I
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

2 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 2

MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or Morphine.

Z-1690-2013
Recall number
Z-1690-2013
Initiated
June 07, 2013
Classification
Class I
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
2 units US and 735 OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Miscalibrated Fill Level Sensor may affect dosing level

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Miscalibrated Fill Level Sensor may affect dosing level

Code information

All serial numbers

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of FL, NC, NJ, and TX, and the countries of Austria, Belgium, Spain, Great Britain, Germany, Italy, Ireland, Luxemburg, Russia, Saudi Arabia, Portugal, Greece, Egypt, Switzerland, and Turkey.

device · product 2 of 2

MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump) 91-4201 (40ml pump) Intended for the intrathecal delivery of Baclofen or Morphine.

Z-1691-2013
Recall number
Z-1691-2013
Initiated
June 07, 2013
Classification
Class I
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
5 US and and 360 OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Miscalibrated Fill Level Sensor may affect dosing level

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Miscalibrated Fill Level Sensor may affect dosing level

Code information

All serial numbers

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of FL, NC, NJ, and TX, and the countries of Austria, Belgium, Spain, Great Britain, Germany, Italy, Ireland, Luxemburg, Russia, Saudi Arabia, Portugal, Greece, Egypt, Switzerland, and Turkey.