Recall Z-1573-2015 ยท CAC Apparatus, Autotransfusion
Stryker Instruments Div. of Stryker Corporation
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.
| Date | May 1, 2015 (initiated Mar 26, 2015) |
| Status | Terminated |
| Reason | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging |
| 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 issue |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970714 | STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII) Stryker Instruments, Dec 16, 1997 |