Z-2261-2019Class II

Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN: JP-2188 An...

Name: Z-2261-2019 Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN: JP-2188 An...
Creator: Degania Silicone, Ltd.
Published: 2019-06-28
License: https://open.fda.gov/license/

Degania Silicone, Inc. / initiated 2019-06-28 / Terminated / root cause: manufacturing process

FDA source

Degania Silicone, Ltd. began a recall of Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN: JP-2188 An introduction/drainage catheter is a device that is a flexible... on 2019-06-28. FDA classified it as Class II and gives the reason as "15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken...". 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-2261-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-28
Posted: 2019-08-12
Terminated: 2020-10-22
Recalling firm: Degania Silicone, Inc.
Product: Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN: JP-2188 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
Product code: GBX Catheter, Irrigation
Reason for recall: 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Degania Silicone Ltd. notified accounts by letter dated June 28, 2019 describing the problem, health risk and action to take: Please forward this information to the immediate attention of the persons responsible for usage of the affected parts. Sub-recall must be initiated by your company to collect any distributed product from the suspected list.2. Please fill in the attached Recall Response form and indicate the quantity of the affected product in your possession. 3. Promptly return the completed Recall Response form to Degania Silicone by e-mail: [email protected]. 4. Disposition of the recalled product: - the preferred option for us is to scrap any recalled product at your facility. In this case we will require official Destruction Confirmation letter containing details of the scrapped product, signed by your company (the draft will be provided by request). - if the above option is not acceptable, we would ask to return any recalled product to our Rhode Island facility. Questions contact Degania Silicone: Degania Silicone Ltd. Degania Bet, 1513000, Israel Katia Kayam, Customer complaints Officer Tel: +972-529532059 E-mail: [email protected]
Quantity in commerce: 3040
Distribution: Nationwide Distribution
Product codes and lots: Lot Codes: P1849762, P1836201, P1864643

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2261-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2260-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2261-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2262-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2263-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2264-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2265-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2266-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12
Z-2267-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-12

Product code GBX

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)