Z-1562-2015Class II

3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved...

Name: Z-1562-2015 3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2015-03-26
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2015-03-26 / Terminated / root cause: packaging

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of 3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar... on 2015-03-26. FDA classified it as Class II and gives the reason as "Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging". 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-1562-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-26
Posted: 2015-05-01
Terminated: 2015-12-31
Recalling firm: Stryker Corp.
Product: 3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
Product code: GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Reason for recall: Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
Root cause tag: packaging
FDA root cause: Package design/selection
Action: An URGENT MEDICAL DEVICE NOTIFICATION letter was sent to all customers on 03/31/2015. The letter identified the affected product, the reason for the recall, the risk to health, and actions to be taken by the customer or user. All are asked to sign the Business Reply Form stating they have read the Notification and followed all instructions within. Customers were asked to immediately check all inventory and quarantine any affected product, return affected product to Stericycle for destruction using a return label provided by Stericycle. Upon receipt of affected product a credit will be issued to customer account.
Quantity in commerce: 2,711 boxes (27,110 each)
Distribution: Worldwide Distribution. US nationwide, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan.
Product codes and lots: Part Number: 0215-015-000 and lot numbers: 10090012 10272012 11110012 11264012 12044012 12249012 13144012 14035012 10104012 10292012 11126012 11269012 12051012 12264012 13176012 14057012 10123012 10320012 11143012 11287012 12081012 12297012 13217012 14088012 10141012 10334012 11146012 11298012 12116012 12339012 13247012 14167012 10158012 10344012 11146022 11318012 12139012 12353012 13266012 14168012 10187012 11005012 11159012 11337012 12152012 13003012 13276012 14213012 10208012 11041012 11194012 11346012 12159012 13008012 13294012 14253012 10228012 11048012 11213012 12011012 12179012 13105012 13312012 14265012 10236012 11075012 11244012 12023012 12228012 13119012 13338012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1562-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1562-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-01
Z-1563-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-01
Z-1564-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-01
Z-1565-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-01
Z-1566-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-01
Z-1567-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-01
Z-1568-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-01
Z-1569-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-01
Z-1570-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-01
Z-1571-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-01
Z-1572-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-01
Z-1573-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-01

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