Z-2150-2017Class II

Jackson-Pratt Silicone Flat Drain, 10mm Full W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt...

Name: Z-2150-2017 Jackson-Pratt Silicone Flat Drain, 10mm Full W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt...
Creator: Cardinal Health 200, LLC
Published: 2017-04-21
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-04-21 / Terminated / root cause: manufacturing process

FDA source

Cardinal Health 200, LLC began a recall of 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... on 2017-04-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2150-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-21
Posted: 2017-05-23
Terminated: 2017-12-27
Recalling firm: Medtronic, Inc.
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. 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
Product code: GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: CardinalHealth sent an Urgent Product Recall letter dated April 21, 2017, to all affected customers (including response firm). Customers were instructed to inspect recalled lots and return any affected product found. Distributors were instructed to notify their customers. Affected product will be destroyed. To arrange for return of any affected product by contacting Customer Service at the following numbers: Hospital800.964.5227 Distributor800.635.6021 Federal Government800.444.1166 All Other Customers888.444.5440 Customers with questions were instructed to contact Cardinal Health Customer Advocacy at 800-292-9332. For questions regarding this recall call 847-887-4138.
Distribution: Nationwide Distribution
Product codes and lots: Catalog Number: SU130-1411 Lot Numbers: 1161253 1161516 1161692

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2150-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2131-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-23
Z-2132-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-23
Z-2133-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-23
Z-2134-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-23
Z-2135-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-23
Z-2136-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-23
Z-2137-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-23
Z-2138-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-23
Z-2139-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-23
Z-2140-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-23
Z-2141-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-23
Z-2142-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-23
Z-2143-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-23
Z-2144-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-23
Z-2145-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-23
Z-2146-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-23
Z-2147-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-23
Z-2148-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-23
Z-2149-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-23
Z-2150-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-23

Product code GCY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)