Cardinal Health 200, LLC: 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.

Agency Publication Date: May 23, 2017

Affected Products

Product: 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 collecti

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

Lot Numbers:

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Product: 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 drai

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

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Product: 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 fl

Catalog Number: JP-HUF101 Lot Numbers: 1161358

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Product: 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 collecti

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

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Product: 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 collecti

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

Lot Numbers:

Numbers

Product: 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. Wo

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

Lot Numbers:

Numbers

Product: 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 collecti

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

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Product: 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 reser

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

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

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Product: 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 d

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

Lot Numbers:

Numbers

Product: 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. Wo

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

Lot Numbers:

Numbers

Product: 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. W

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

Lot Numbers:

Numbers

Product: 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. W

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

Lot Numbers:

Numbers

Product: 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.

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

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Product: 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

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

Lot Numbers:

Numbers

Product: 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

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

Lot Numbers:

Numbers

Product: 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

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

Lot Numbers:

Numbers

Product: 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 drain

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

Lot Numbers:

Numbers

Product: 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.

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

Lot Numbers:

Numbers

Product: 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

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

Lot Numbers:

Numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77127

Status: Resolved

Manufacturer: Cardinal Health 200, LLC

Manufactured In: United States

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

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

Lot Numbers:

Numbers

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

Lot Numbers:

Numbers

Catalog Number: JP-HUF101 Lot Numbers: 1161358

Lot Numbers:

Numbers

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

Lot Numbers:

Numbers

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

Lot Numbers:

Numbers

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

Lot Numbers:

Numbers

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

Lot Numbers:

Numbers

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

Lot Numbers:

Numbers

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

Lot Numbers:

Numbers

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

Lot Numbers:

Numbers

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

Lot Numbers:

Numbers

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

Lot Numbers:

Numbers

Lot Numbers:

Numbers

Lot Numbers:

Numbers

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

Lot Numbers:

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

Lot Numbers:

Numbers

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

Lot Numbers:

Numbers

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

Lot Numbers:

Numbers

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

Lot Numbers:

Numbers

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

Lot Numbers:

Numbers