Z-1566-2015Class II

1/4 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved...

Name: Z-1566-2015 1/4 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 1/4 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-1566-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-26
Posted: 2015-05-01
Terminated: 2015-12-31
Recalling firm: Stryker Corp.
Product: 1/4 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: 1,984 boxes (19,840 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: 0215-019-000 and lot numbers: 10095012 10312012 11060012 11186012 11346012 12115012 12349012 13262012 10109012 10321012 11067012 11192012 11356012 12157012 13017012 13277012 10127012 10347012 11088012 11220012 12003012 12193012 13023012 13347012 10189012 10355012 11097012 11230012 12009012 12206012 13044012 14020012 10195012 11011012 11117012 11269012 12026012 12235012 13063012 14030012 10274012 11039012 11136012 11286012 12031012 12290012 13145012 14039012 10285012 11059012 11178012 11335012 12060012 12310012 13254012 14066012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1566-2015
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)