Recall Z-1573-2015
Stryker Instruments Div. of Stryker Corporation · initiated March 26, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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
Reason for recall
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
FDA-determined cause: Package design/selection
Action taken
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.
Details
- Recall number
- Z-1573-2015
- Initiated
- March 26, 2015
- Posted by FDA
- May 1, 2015
- Terminated
- December 31, 2015
- Product code
- CAC – Apparatus, Autotransfusion
- Quantity
- 2,575 boxes (25,750 each)
- Distribution
- Worldwide Distribution. US nationwide, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan.
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation, Portage, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1562-2015 Class II | 3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | 03/26/2015Terminated |
| Z-1563-2015 Class II | 3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | 03/26/2015Terminated |
| Z-1564-2015 Class II | 1/8 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | 03/26/2015Terminated |
| Z-1565-2015 Class II | 1/8 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | 03/26/2015Terminated |
| Z-1566-2015 Class II | 1/4 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | 03/26/2015Terminated |
| Z-1567-2015 Class II | 1/4 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | 03/26/2015Terminated |
| Z-1568-2015 Class II | 3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | 03/26/2015Terminated |
| Z-1569-2015 Class II | 1/4 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | 03/26/2015Terminated |
| Z-1570-2015 Class II | 3/16 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | 03/26/2015Terminated |
| Z-1571-2015 Class II | 1/8 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | 03/26/2015Terminated |
| Z-1572-2015 Class II | 1/4 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | 03/26/2015Terminated |