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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85751

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

Open FDA event record

Event summary

Timeline bucket
May 28, 2020
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

14 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 14

Thora-Para 5 Fr Non-Valved Catheter Drainage Tray

Z-2646-2020
Recall number
Z-2646-2020
Initiated
May 28, 2020
Classification
Class II
Status
Terminated
Recalling firm
Carefusion 2200 Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

Code information

Catalog: OTP5000; UDI: 50885403284746; Batches 0001319437, 0001320128, 0001321277, 0001321728, 0001322907, 0001324316, 0001332577, 0001334404, 0001335108, 0001336587, 0001337314, 0001338451, 0001339415, 0001341205, 0001342585, 0001344650, 0001346669, 0001346992

Distribution pattern

370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY Customer listed, including Federal distribution, uploaded.

device · product 2 of 14

Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Tray

Z-2647-2020
Recall number
Z-2647-2020
Initiated
May 28, 2020
Classification
Class II
Status
Terminated
Recalling firm
Carefusion 2200 Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

Code information

Catalog: OTP5000SP; UDI: 50885403284746; Batch 0001337784

Distribution pattern

370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY Customer listed, including Federal distribution, uploaded.

device · product 3 of 14

Safe-T-Centesis 6 Fr Catheter Drainage Tray

Z-2648-2020
Recall number
Z-2648-2020
Initiated
May 28, 2020
Classification
Class II
Status
Terminated
Recalling firm
Carefusion 2200 Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

Code information

Catalog: PIG1260T; UDI: 50885403108363; Batches: 0001319266, 0001320359, 0001320361, 0001321495, 0001321903, 0001322646, 0001323766, 0001324093, 0001324318, 0001331342, 0001332814, 0001332817, 0001333972, 0001335443, 0001335444, 0001335695, 0001336580, 0001336581, 0001336582, 0001336962, 0001336963, 0001337307, 0001337983, 0001338432, 0001338452, 0001339413, 0001339782, 0001339783, 0001341546, 0001342258, 0001342587, 0001343637, 0001343638, 0001344743, 0001346287, 0001346479, 0001346480

Distribution pattern

370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY Customer listed, including Federal distribution, uploaded.

device · product 4 of 14

Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine

Z-2649-2020
Recall number
Z-2649-2020
Initiated
May 28, 2020
Classification
Class II
Status
Terminated
Recalling firm
Carefusion 2200 Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

Code information

Catalog: PIG1260TCDF UDI: 50885403231894; Batches 0001335833 and 0001341627

Distribution pattern

370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY Customer listed, including Federal distribution, uploaded.

device · product 5 of 14

Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray

Z-2650-2020
Recall number
Z-2650-2020
Initiated
May 28, 2020
Classification
Class II
Status
Terminated
Recalling firm
Carefusion 2200 Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

Code information

Catalog: PIG1260TSP UDI: 50885403108387; Batches: 0001319377, 0001321496, 0001324092, 0001333971, 0001335442, 0001336583, 0001336964, 0001338981, 0001343845, 0001344649, 0001346293

Distribution pattern

370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY Customer listed, including Federal distribution, uploaded.

device · product 6 of 14

Safe-T-Centesis 8 Fr Catheter Drainage Tray

Z-2651-2020
Recall number
Z-2651-2020
Initiated
May 28, 2020
Classification
Class II
Status
Terminated
Recalling firm
Carefusion 2200 Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

Code information

Catalog: PIG1280T UDI: 50885403108400; Batches: 0001320864, 0001321078, 0001333781, 0001335698, 0001336588, 0001337539, 0001341632, 0001345260

Distribution pattern

370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY Customer listed, including Federal distribution, uploaded.

device · product 7 of 14

Safe-T-Centesis PLUS 8 Fr Catheter Drainage Tray

Z-2652-2020
Recall number
Z-2652-2020
Initiated
May 28, 2020
Classification
Class II
Status
Terminated
Recalling firm
Carefusion 2200 Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

Code information

Catalog: PIG1280TSP UDI: 50885403108424; Batches: 0001320865, 0001321079, 0001333154, 0001333780, 0001335440, 0001338450, 0001341635

Distribution pattern

370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY Customer listed, including Federal distribution, uploaded.

device · product 8 of 14

Thora-Para 8 Fr Catheter Drainage Tray

Z-2653-2020
Recall number
Z-2653-2020
Initiated
May 28, 2020
Classification
Class II
Status
Terminated
Recalling firm
Carefusion 2200 Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

Code information

Catalog: TPT1000 UDI: 50885403108486; Batches: 0001319053, 0001319438, 0001320227, 0001320514, 0001321276, 0001321497, 0001322638, 0001322905, 0001323536, 0001323775, 0001332576, 0001334403, 0001334406, 0001335268, 0001335696, 0001336965, 0001338449, 0001338788, 0001338789, 0001339414, 0001339562, 0001341206, 0001341633, 0001342263, 0001343223, 0001343636, 0001344137, 0001346668, 0001346670, 0001346671

Distribution pattern

370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY Customer listed, including Federal distribution, uploaded.

device · product 9 of 14

Thora-Para 8 Fr Catheter Drainage Tray w/o Lidocaine

Z-2654-2020
Recall number
Z-2654-2020
Initiated
May 28, 2020
Classification
Class II
Status
Terminated
Recalling firm
Carefusion 2200 Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

Code information

Catalog: TPT1000CDF UDI: 50885403231900; Batch 0001333309

Distribution pattern

370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY Customer listed, including Federal distribution, uploaded.

device · product 10 of 14

Safe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and Sharps Injury Protection - Drug Free

Z-2655-2020
Recall number
Z-2655-2020
Initiated
May 28, 2020
Classification
Class II
Status
Terminated
Recalling firm
Carefusion 2200 Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

Code information

Catalog: TPT1000SDF UDI: 50885403108493; Batches: 0001320515, 0001321729, 0001323273, 0001323703, 0001332819, 0001334405, 0001338453, 0001344142, 0001344740

Distribution pattern

370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY Customer listed, including Federal distribution, uploaded.

device · product 11 of 14

Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray

Z-2656-2020
Recall number
Z-2656-2020
Initiated
May 28, 2020
Classification
Class II
Status
Terminated
Recalling firm
Carefusion 2200 Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

Code information

Catalog: TPT1000SP UDI: 50885403108431; Batches: 0001319836, 0001320129, 0001321726, 0001321727, 0001322906, 0001323275, 0001324091, 0001324317, 0001333308, 0001333777, 0001334187, 0001335697, 0001337779, 0001337982, 0001341544, 0001342586, 0001344739, 0001346286

Distribution pattern

370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY Customer listed, including Federal distribution, uploaded.

device · product 12 of 14

Thora-Para 5 Fr Catheter Drainage Tray

Z-2657-2020
Recall number
Z-2657-2020
Initiated
May 28, 2020
Classification
Class II
Status
Terminated
Recalling firm
Carefusion 2200 Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

Code information

Catalog: TPT1005 UDI: 50885403220850; Batches: 0001320127, 0001323274, 0001333152, 0001335109, 0001339556, 0001345011

Distribution pattern

370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY Customer listed, including Federal distribution, uploaded.

device · product 13 of 14

Safe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection - Drug Free

Z-2658-2020
Recall number
Z-2658-2020
Initiated
May 28, 2020
Classification
Class II
Status
Terminated
Recalling firm
Carefusion 2200 Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

Code information

Catalog: TPT1005SDF UDI: 50885403228139; Batches: 0001333153 and 0001339557

Distribution pattern

370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY Customer listed, including Federal distribution, uploaded.

device · product 14 of 14

Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray

Z-2659-2020
Recall number
Z-2659-2020
Initiated
May 28, 2020
Classification
Class II
Status
Terminated
Recalling firm
Carefusion 2200 Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

Code information

Catalog: TPT1005SP UDI: 50885403220867; Batch: 0001345010

Distribution pattern

370 US customers and 13 distributors. Product distributed in: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MD, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY Customer listed, including Federal distribution, uploaded.