Z-1233-2017Class II

Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal...

Name: Z-1233-2017 Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal...
Creator: Degania Silicone, Ltd.
Published: 2017-01-31
License: https://open.fda.gov/license/

Degania Silicone, Inc. / initiated 2017-01-31 / Terminated / root cause: packaging

FDA source

Degania Silicone, Ltd. began a recall of Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound... on 2017-01-31. FDA classified it as Class II and gives the reason as "Product sterility compromised due to breach of sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1233-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-31
Posted: 2017-02-22
Terminated: 2017-04-04
Recalling firm: Degania Silicone, Inc.
Product: Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound drainage.
Product code: GBX Catheter, Irrigation
Reason for recall: Product sterility compromised due to breach of sterile barrier
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Degania Silicone Ltd. issued an Urgent Recall letter dated 1/31/17 and requested return of the product to Degania Silicone 14 Thurber Boulevard, Suite A, Smithfield, RI 02917, USA.. For questions regarding this recall call +1-401-349-5373.
Quantity in commerce: 3040 units
Distribution: To PR only
Product codes and lots: Lot Number: P1546816 Expiration date: January 2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1233-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1233-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-22

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)