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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65821

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

Open FDA event record

Event summary

Timeline bucket
August 13, 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

8 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 8

MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.

Z-2293-2013
Recall number
Z-2293-2013
Initiated
August 13, 2013
Classification
Class I
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Drug flow rates exceeding programmed flow rates.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Drug flow rates exceeding programmed flow rates.

Code information

Lot/Serial Number US: NMBJ7K, NMBJ5C

Distribution pattern

Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.

device · product 2 of 8

MedStream Programmable Pump; 40ml - 91-4201US Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.

Z-2294-2013
Recall number
Z-2294-2013
Initiated
August 13, 2013
Classification
Class I
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Drug flow rates exceeding programmed flow rates.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Drug flow rates exceeding programmed flow rates.

Code information

Lot/Serial Number US: NMBKB6, NMBKFF, NMBKC5, NMBKCF, NMBJ3K

Distribution pattern

Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.

device · product 3 of 8

MedStream Refill Kit, U.S: 91-4287 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.

Z-2295-2013
Recall number
Z-2295-2013
Initiated
August 13, 2013
Classification
Class I
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Drug flow rates exceeding programmed flow rates.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Drug flow rates exceeding programmed flow rates.

Code information

Lot/Serial Number US: 13B090CT

Distribution pattern

Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.

device · product 4 of 8

MedStream Refill Kit (1 unit), EMEA: 91-4289 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.

Z-2296-2013
Recall number
Z-2296-2013
Initiated
August 13, 2013
Classification
Class I
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
OUS: 2168 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Drug flow rates exceeding programmed flow rates.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Drug flow rates exceeding programmed flow rates.

Code information

OUS: Per recall strategy

Distribution pattern

Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.

device · product 5 of 8

MedStream Refill Kit (6 units), EMEA: 91-4290 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.

Z-2297-2013
Recall number
Z-2297-2013
Initiated
August 13, 2013
Classification
Class I
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
832 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Drug flow rates exceeding programmed flow rates.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Drug flow rates exceeding programmed flow rates.

Code information

OUS: Per recall strategy

Distribution pattern

Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.

device · product 6 of 8

MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.

Z-2298-2013
Recall number
Z-2298-2013
Initiated
August 13, 2013
Classification
Class I
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
0 - product used for internal training purposes only

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Drug flow rates exceeding programmed flow rates.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Drug flow rates exceeding programmed flow rates.

Code information

Unavailable

Distribution pattern

Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.

device · product 7 of 8

MedStream Programmable Pump; 40ml Pump EMEA 91-4201 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.

Z-2299-2013
Recall number
Z-2299-2013
Initiated
August 13, 2013
Classification
Class I
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
369 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Drug flow rates exceeding programmed flow rates.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Drug flow rates exceeding programmed flow rates.

Code information

OUS: Per recall strategy

Distribution pattern

Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.

device · product 8 of 8

MedStream Programmable Pump; 20ml Pump EMEA 91-4200 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.

Z-2300-2013
Recall number
Z-2300-2013
Initiated
August 13, 2013
Classification
Class I
Status
Terminated
Recalling firm
Codman & Shurtleff, Inc.
Quantity
735 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Drug flow rates exceeding programmed flow rates.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Drug flow rates exceeding programmed flow rates.

Code information

OUS: Per recall strategy

Distribution pattern

Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.

Field note

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