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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76620

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

Open FDA event record

Event summary

Timeline bucket
February 23, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Carefusion 2200 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

6 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 6

Manometer, 550 ml three-Way Stopcock; STERILE;

Z-1421-2018
Recall number
Z-1421-2018
Initiated
February 23, 2017
Classification
Class II
Status
Terminated
Recalling firm
Carefusion 2200 Inc
Quantity
4,240 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging is potentially compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The integrity of the sterile packaging is potentially compromised.

Code information

Product Code: 4330 Lot Code: 0000837810; 0000840335; 0000842213; 0000848531; 0000851181; 0000853962

Distribution pattern

Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam

device · product 2 of 6

JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;

Z-1422-2018
Recall number
Z-1422-2018
Initiated
February 23, 2017
Classification
Class II
Status
Terminated
Recalling firm
Carefusion 2200 Inc
Quantity
790 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging is potentially compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The integrity of the sterile packaging is potentially compromised.

Code information

Product Code: SN1015X / LOT 0000840334 ; Product Code: SN1016X / LOT 0000848028 ; Product Code: SN1017X / LOT 0000848018 ; Product Code SN7016X / LOT 0000848017

Distribution pattern

Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam

device · product 3 of 6

ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE;

Z-1423-2018
Recall number
Z-1423-2018
Initiated
February 23, 2017
Classification
Class II
Status
Terminated
Recalling firm
Carefusion 2200 Inc
Quantity
a.) 13,010 units b.) 2116 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging is potentially compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The integrity of the sterile packaging is potentially compromised.

Code information

Product Code: a.) TIN3015/ LOT 0000836578, 0000841213, 0000841215, 0000842719, 0000842721, 0000845423, 0000848061, 0000849715, 0000850938, 0000852076, 0000854859; Product Code: b.) TIN3018/ LOT 0000836574, 0000841212, 0000852078

Distribution pattern

Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam

device · product 4 of 6

JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;

Z-1424-2018
Recall number
Z-1424-2018
Initiated
February 23, 2017
Classification
Class II
Status
Terminated
Recalling firm
Carefusion 2200 Inc
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging is potentially compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The integrity of the sterile packaging is potentially compromised.

Code information

Product Code: a.) TJC3513 / LOT 0000848831, 0000851431, 0000854856; Product Code: b.) TJC4008 / LOT 0000841227, 0000846706, 0000848560, 0000849684, 0000853455; c.) TJC4011 / LOT 0000840667, 0000841228, 0000845874, 0000849717, 0000850937, 0000852121; d.) TJC6008 / LOT 0000841216, 0000848569, 0000851432, 0000852122, 0000853458; e.) TJC6011 / LOT 0000841124, 0000848571, 0000853975

Distribution pattern

Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam

device · product 5 of 6

JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;

Z-1425-2018
Recall number
Z-1425-2018
Initiated
February 23, 2017
Classification
Class II
Status
Terminated
Recalling firm
Carefusion 2200 Inc
Quantity
14,200 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging is potentially compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The integrity of the sterile packaging is potentially compromised.

Code information

Product Code: a.) TJM3513 / LOT 0000836582, 0000838949, 0000843968, 0000849685, 0000852933; b.) TJM4008 / LOT 0000841349, 0000841348, 0000843961, 0000849132, 0000852123, 0000853877; c.) TJM4011 / LOT 0000836575, 0000838950, 0000840195, 0000843075, 0000843076, 0000846708, 0000852932, 0000853878, 0000854861, 0000854983; d.) TJM6008 / LOT 0000842725, 0000853971; e.) TJM6011 / LOT 0000843077, 0000849713, 0000854659

Distribution pattern

Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam

device · product 6 of 6

Thoracentesis/ Paracentesis Kit 10/CS; STERILE;

Z-1426-2018
Recall number
Z-1426-2018
Initiated
February 23, 2017
Classification
Class II
Status
Terminated
Recalling firm
Carefusion 2200 Inc
Quantity
1200 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging is potentially compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The integrity of the sterile packaging is potentially compromised.

Code information

Product Code: TPK1001 / LOT 0000837811, 0000842215, 0000840336, 0000851185

Distribution pattern

Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam