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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83287

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

Open FDA event record

Event summary

Timeline bucket
June 28, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Degania Silicone, Ltd.

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

Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.

Z-2260-2019
Recall number
Z-2260-2019
Initiated
June 28, 2019
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
640 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body

Code information

Lot Codes: 1900956, P1900955

Distribution pattern

Nationwide Distribution

device · product 2 of 8

Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN: JP-2188 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.

Z-2261-2019
Recall number
Z-2261-2019
Initiated
June 28, 2019
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
3040

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body

Code information

Lot Codes: P1849762, P1836201, P1864643

Distribution pattern

Nationwide Distribution

device · product 3 of 8

Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product Number: JP-2189 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.

Z-2262-2019
Recall number
Z-2262-2019
Initiated
June 28, 2019
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
6080

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body

Code information

Lot Codes: P1841752 P1852268 P1845823

Distribution pattern

Nationwide Distribution

device · product 4 of 8

Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Health: PN JP-2190 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.

Z-2263-2019
Recall number
Z-2263-2019
Initiated
June 28, 2019
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
4080

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body

Code information

Lot Code: P1849695, P1858286, P1867022

Distribution pattern

Nationwide Distribution

device · product 5 of 8

Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal Health: PN: JP-2191 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.

Z-2264-2019
Recall number
Z-2264-2019
Initiated
June 28, 2019
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
6960

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body

Code information

Lot Codes: P1861538 P1865416 P1903570

Distribution pattern

Nationwide Distribution

device · product 6 of 8

Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2225 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.

Z-2265-2019
Recall number
Z-2265-2019
Initiated
June 28, 2019
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
2160

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body

Code information

Lot Codes: P1851056 P1867059

Distribution pattern

Nationwide Distribution

device · product 7 of 8

Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.

Z-2266-2019
Recall number
Z-2266-2019
Initiated
June 28, 2019
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
200

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body

Code information

Lot Code: P1841839

Distribution pattern

Nationwide Distribution

device · product 8 of 8

Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN: 02872 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.

Z-2267-2019
Recall number
Z-2267-2019
Initiated
June 28, 2019
Classification
Class II
Status
Terminated
Recalling firm
Degania Silicone, Ltd.
Quantity
2700

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body

Code information

Lot Code: P1838322, P1858869

Distribution pattern

Nationwide Distribution