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: SU130-1311 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

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-2144-2017
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, 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

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Is Jackson-Pratt Silicone Flat Drain, Full Ducts recalled?

Yes. Cardinal Health 200 recalled Jackson-Pratt Silicone Flat Drain, Full Ducts on 21 Apr 2017. The recall is Class II and its status is Terminated. Recall number Z-2144-2017.

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: SU130-1311 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

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

More recalls from Cardinal Health 200

All 283

Other Surgical Instruments recalls

All 3,809