Z-1573-2015Class II

Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir...

Name: Z-1573-2015 Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir...
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 Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir, the PVC tubing, the slide clamp and the female... 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-1573-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-26
Posted: 2015-05-01
Terminated: 2015-12-31
Recalling firm: Stryker Corp.
Product: Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir, the PVC tubing, the slide clamp and the female connector. The rigid polycarbonate female connector is used to connect the ambulating bulb to the CBCII evacuator tube in order to collect wound drainage.
Product code: CAC Apparatus, Autotransfusion
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: 2,575 boxes (25,750 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:0225-028-852 and lot numbers: 10097012 10281012 11087012 11178012 12066012 12335012 13234012 14178012 10105012 10298012 11095012 11189012 12101012 12348012 13248012 14197012 10130012 10312012 11105012 11206012 12108012 12353012 13263012 14254012 10162012 10322012 11115012 11229012 12138012 13046012 13302012 14260012 10172012 10337012 11130012 11269012 12156012 13086012 13319012 10195012 10340012 11139012 11313012 12159012 13095012 14029012 10205012 11003012 11146012 11337012 12199012 13108012 14052012 10238012 11013012 11147012 12016012 12248012 13143012 14058012 10251012 11048012 11151012 12040012 12261012 13171012 14155012 10272012 11055012 11160012 12041012 12289012 13221012 14164012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1573-2015
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 CAC

K970714Class IIStryker Constavac Blood Conservation System II (Cbcii)Stryker Instruments / cleared 1997-12-16

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)