CLASS II Device recall · Reported 31 May 2017 · FDA Enforcement Report

Jackson-Pratt Silicone Flat Drain, Full Ducts recalled

Cardinal Health 200 is recalling Jackson-Pratt Silicone Flat Drain, Full Ducts, distributed nationwide in the US. The recall was initiated on 21 Apr 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog 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

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2143-2017
FDA event ID
77127
Recalling firm
Cardinal Health 200, Waukegan, IL
Classification
Class II
Status
Terminated
Recall initiated
21 Apr 2017
FDA classified
23 May 2017
Reported
31 May 2017
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

21 Apr 2017Recall initiated by company
23 May 2017Classified by FDA+32 days
31 May 2017Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

19 other products · FDA event 77127

This product is part of a recall event; the main page for the event is Jackson-Pratt Silicone Flat Drain, 3/4 Ducts recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIJackson-Pratt Silicone Flat Drain, 3/4 Ducts recalledCardinal Health 200SterilityNationwide
CLASS IIJackson-Pratt PVC Round Drain W/Trocar recalled by Cardinal Health 200Cardinal Health 200SterilityNationwide
CLASS IIJackson-Pratt Silicone Flat Drain, Full Ducts recalledCardinal Health 200SterilityNationwide
CLASS IIJackson-Pratt Hemaduct Silicone Flat Drain recalledCardinal Health 200SterilityNationwide
CLASS IIJackson-Pratt Silicone Round Drain recalled by Cardinal Health 200Cardinal Health 200SterilityNationwide
CLASS IIJackson-Pratt Silicone Round Drain recalled by Cardinal Health 200Cardinal Health 200SterilityNationwide
CLASS IIJackson-Pratt Silicone Round Drain recalled by Cardinal Health 200Cardinal Health 200SterilityNationwide
CLASS IIJackson-Pratt Hemaduct Silicone Round Drain recalledCardinal Health 200SterilityNationwide
CLASS IIJackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain recalledCardinal Health 200SterilityNationwide
CLASS IIJackson-Pratt Hemaduct Silicone Round Drain W/Trocar recalledCardinal Health 200SterilityNationwide
CLASS IIJackson-Pratt Hemaduct Silicone Round Drain W/ Trocar recalledCardinal Health 200SterilityNationwide
CLASS IIJackson-Pratt Silicone Round Drain recalled by Cardinal Health 200Cardinal Health 200SterilityNationwide
CLASS IIJackson-Pratt Hemaduct Silicone Round Drain W/ Trocar recalledCardinal Health 200SterilityNationwide
CLASS IIJackson-Pratt Hemaduct Silicone Flat Drain, Full Ducts W/ Trocar recalledCardinal Health 200SterilityNationwide
CLASS IIJackson-Pratt Silicone Flat Drain Full W/Trocar recalledCardinal Health 200SterilityNationwide
CLASS IIJackson-Pratt Hemaduct Silicone Round Drain W/Trocar recalledCardinal Health 200SterilityNationwide
CLASS IIJackson-Pratt Silicone Flat Drain Full W/Trocar recalledCardinal Health 200SterilityNationwide
CLASS IIJackson-Pratt Silicone Flat Drain, 3/4 Ducts recalledCardinal Health 200SterilityNationwide
CLASS IIJackson-Pratt Hemaduct Silicone Round Drain W/ Trocar recalledCardinal Health 200SterilityNationwide

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