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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77127

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

Open FDA event record

Event summary

Timeline bucket
April 21, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cardinal Health 200, LLC

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

20 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 20

Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

Z-2131-2017
Recall number
Z-2131-2017
Initiated
April 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal possibly compromised, potentially compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Code information

Catalog Number: CT-HU1900 Lot Numbers: 1161200 1161362 1161455 1161599

Distribution pattern

Nationwide Distribution

device · product 2 of 20

Jackson-Pratt Hemaduct Silicone Flat Drain. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

Z-2132-2017
Recall number
Z-2132-2017
Initiated
April 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal possibly compromised, potentially compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Code information

Catalog Number: JP-HUF100 Lot Numbers: 1161357 1161466 1170015

Distribution pattern

Nationwide Distribution

device · product 3 of 20

Jackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

Z-2133-2017
Recall number
Z-2133-2017
Initiated
April 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal possibly compromised, potentially compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Code information

Catalog Number: JP-HUF101 Lot Numbers: 1161358

Distribution pattern

Nationwide Distribution

device · product 4 of 20

Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/10FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

Z-2134-2017
Recall number
Z-2134-2017
Initiated
April 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal possibly compromised, potentially compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Code information

Catalog Number: JP-HUR101 Lot Numbers: 1161193 1161194 1161359 1161467 1161468 1161591 1161592

Distribution pattern

Nationwide Distribution

device · product 5 of 20

Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

Z-2135-2017
Recall number
Z-2135-2017
Initiated
April 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal possibly compromised, potentially compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Code information

Catalog Number: JP-HUR151 Lot Numbers: 1161195 1161196 1161360 1161456 1161593 1170021 1170022

Distribution pattern

Nationwide Distribution

device · product 6 of 20

Jackson-Pratt Hemaduct Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

Z-2136-2017
Recall number
Z-2136-2017
Initiated
April 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal possibly compromised, potentially compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Code information

Catalog Number: JP-HUR190 Lot Numbers: 1161197 1161198 1161457 1161597

Distribution pattern

Nationwide Distribution

device · product 7 of 20

Jackson-Pratt Hemaduct Silicone Round Drain, 19FR W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

Z-2137-2017
Recall number
Z-2137-2017
Initiated
April 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal possibly compromised, potentially compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Code information

Catalog Number: JP-HUR195 Lot Numbers: 1161199 1161361 1161458 1161459 1161594 1161595 1161596

Distribution pattern

Nationwide Distribution

device · product 8 of 20

Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

Z-2138-2017
Recall number
Z-2138-2017
Initiated
April 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal possibly compromised, potentially compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Code information

Catalog Number: SU130-0321 Lot Numbers: 1161202 1161203 1161364 1161365 1161471 1161472 1161601 1161602 1170030 1170031

Distribution pattern

Nationwide Distribution

device · product 9 of 20

Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

Z-2139-2017
Recall number
Z-2139-2017
Initiated
April 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal possibly compromised, potentially compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Code information

Catalog Number: SU130-0323 Lot Numbers: 1161366 1161473 1161603 1161604 1161605 1170033

Distribution pattern

Nationwide Distribution

device · product 10 of 20

Jackson-Pratt PVC Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

Z-2140-2017
Recall number
Z-2140-2017
Initiated
April 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal possibly compromised, potentially compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Code information

Catalog Number: SU130-0521 Lot Numbers: 1161481 1170193 1170194

Distribution pattern

Nationwide Distribution

device · product 11 of 20

Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

Z-2141-2017
Recall number
Z-2141-2017
Initiated
April 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal possibly compromised, potentially compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Code information

Catalog Number: SU130-1308 Lot Numbers: 1161228 1161229 1161396 1161397 1161490 1161491

Distribution pattern

Nationwide Distribution

device · product 12 of 20

Jackson-Pratt Silicone Flat Drain, 10mm, 3/4 Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

Z-2142-2017
Recall number
Z-2142-2017
Initiated
April 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal possibly compromised, potentially compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Code information

Catalog Number: SU130-1309 Lot Numbers: 1161246 1161412 1161413 1161460 1161461 1161619 1161620 1161621 1170083 1170084

Distribution pattern

Nationwide Distribution

device · product 13 of 20

Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

Z-2143-2017
Recall number
Z-2143-2017
Initiated
April 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal possibly compromised, potentially compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Code information

Catalog Number: SU130-1310 Lot Numbers: 1161230 1161231 1161232 1161233 1161234 1161398 1161399 1161400 1161401 1161402 1161403 1161404 1161492 1161493 1161494 1161495 1161496 1161497 1161498 1161499 1161614 1161615 1161616 1161617 1170076 1170077 1170080

Distribution pattern

Nationwide Distribution

device · product 14 of 20

Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

Z-2144-2017
Recall number
Z-2144-2017
Initiated
April 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal possibly compromised, potentially compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Code information

Catalog Number: SU130-1311 Lot Numbers: 1161247 1161248 1161249 1161250 1161251 1161252 1161414 1161415 1161416 1161417 1161418 1161419 1161420 1161421 1161509 1161510 1161511 1161512 1161513 1161514 1161515 1161622 1161623 1161624 1161625 1161626 1161627 1161628 1170089 1170094 1170095 1170096 1170353 1170354 1170356

Distribution pattern

Nationwide Distribution

device · product 15 of 20

Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

Z-2145-2017
Recall number
Z-2145-2017
Initiated
April 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal possibly compromised, potentially compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Code information

Catalog Number: SU130-1320 Lot Numbers: 1161205 1161368 1161369 1161475

Distribution pattern

Nationwide Distribution

device · product 16 of 20

Jackson-Pratt Silicone Round Drain, 10FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

Z-2146-2017
Recall number
Z-2146-2017
Initiated
April 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal possibly compromised, potentially compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Code information

Catalog Number: SU130-1321 Lot Numbers: 1161206 1161207 1161370 1161371 1161372 1161476 1161477 1161478 1161606 1161607 1161608 1170036

Distribution pattern

Nationwide Distribution

device · product 17 of 20

Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

Z-2147-2017
Recall number
Z-2147-2017
Initiated
April 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal possibly compromised, potentially compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Code information

Catalog Number: SU130-1323 Lot Numbers: 1161373 1161374 1161375 1161610 1161611 1170038 1170039

Distribution pattern

Nationwide Distribution

device · product 18 of 20

Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

Z-2148-2017
Recall number
Z-2148-2017
Initiated
April 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal possibly compromised, potentially compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Code information

Catalog Number: SU130-1325 Lot Numbers: 1161208 1161209 1161376 1161479 1161480 1161612 1161613 1170040

Distribution pattern

Nationwide Distribution

device · product 19 of 20

Jackson-Pratt Silicone Flat Drain, 7mm Full W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

Z-2149-2017
Recall number
Z-2149-2017
Initiated
April 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal possibly compromised, potentially compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Code information

Catalog Number: SU130-1410 Lot Numbers: 1161405 1161584 1161618

Distribution pattern

Nationwide Distribution

device · product 20 of 20

Jackson-Pratt Silicone Flat Drain, 10mm Full W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

Z-2150-2017
Recall number
Z-2150-2017
Initiated
April 21, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
Unavailable

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal possibly compromised, potentially compromising the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection.

Code information

Catalog Number: SU130-1411 Lot Numbers: 1161253 1161516 1161692

Distribution pattern

Nationwide Distribution