Recall Z-1569-2015
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
1/4 in. Round Drain with Trocar 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.
Codes / lots: Part Number: 0215-032-000 and lot numbers: 10098012 10279012 11017012 11131012 12033012 12275012 13128012 14063012 10165012 10343012 11122012 11159012 12137012 13025012 13343012 14105012
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-1569-2015
- Initiated
- March 26, 2015
- Posted by FDA
- May 1, 2015
- Terminated
- December 31, 2015
- Product code
- GCY – Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- Quantity
- 300 boxes (3,000 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-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 |
| Z-1573-2015 Class II | Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the…Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential… | 03/26/2015Terminated |