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PRODUCT
1) Stryker CBCII ConstaVac Blood conservation system, sterile, REF 225-28E. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0719-2010;
2) Stryker CBCII collection only pkg/6, sterile, REF 225-28-S20. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0720-2010;
3) Stryker CBC Blood Conservation Kit with Quick Disconnect Blood Bag, sterile, REF 225-28-85. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0721-2010;
4) Stryker CBCII 1/8in. Double Trocar with quick disconnect , sterile, REF225-28-85S1. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0722-2010;
5) Stryker CBCII with Quick Disconnect, 3/16 in. Double Trocar and Reinfusion Labels, sterile, REF 225-28-85S4. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0723-2010;
6) Stryker CBCII with Quick Disconnect and 3/16 in. Double Trocar, sterile, REF 225-28-S5. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0724-2010;
7) Stryker CBCII Blood Conservation Kit w/ 1/8 in. (3.2mm) Round PVC Drain and Curved Trocar, sterile; REF 225-28-514. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0725-2010;
8) Stryker CBCII Blood Conservation Kit w/ 1/4 in. (6.4mm) Round PVC Drain and Curved Trocar, sterile, REF 225-28-516. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0726-2010;
9) Stryker CBCII Blood Conservation Kit w 3/16in. (4.8mm) round PVC Drain and Curved Trocar, sterile, REF 225-28-526. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0727-2010;
10) Stryker CBCII Double Trocar Kit with 1/8 in. (3.2mm) Drain, sterile, REF 225-28-614. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0728-2010;
11) Stryker CBCII Double Trocar Kit with 1/4in. (6.4mm) Drain, sterile, REF 225-28-616. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0729-2010;
12) Stryker CBCII Double Trocar Kit with 3/16in. (4.8mm) Drain, sterile, REF 225-28-626. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0730-2010;
13) Stryker CBCII Double Trocar/Double Pouch Kit with 3/16in. (4.8mm) Drain, sterile, REF 225-28-626S1. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0731-2010;
14) Stryker CBCII ConstaVac Blood Conservagtion System w/ Quick Disconnect and 1/8in. (3.2mm) PVC Drain, sterile, REF 225-28-914. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0732-2010;
15) Stryker CBCII ConstaVac Blood Conservation System with Quick Disconnect and 1/4in. (6.4mm) PVC Drain, sterile, REF 225-28-916. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0733-2010;
16) Stryker CBCII ConstaVac Blood Conservation System w/Quick Disconnect and 3/16in. (4.8mm) PVC Drain, sterile, REF 225-28-926. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0734-2010;
17) Stryker CBCII ConstaVac Blood Collection Only System with 1/8in. (3.2mm) PVC Drains and Double 1/8in. (3.2mm) Trocar, sterile, REF 225-29. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0735-2010;
18) Stryker CBCII ConstaVAc Blood Conservatin Kit 1/8in. (3.2mm) PVC, sterile, REF 225-414. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0736-2010;
19) Stryker CBCII ConstaVac Blood Conservation Kit 1/8in. (3.2mm) PVC w/o Fat Retention Valve, sterile, REF 225-414S2. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0737-2010;
20) Stryker CBCII ConstaVac Blood Conservaion Kit 1/8in. (3.2mm) PVC, sterile, REF 225-414-W. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0738-2010;
21) Stryker CBCII ConstaVac Blood Conservation Kit 1/4in. (6.4mm) PVC, sterile, REF 225-416. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0739-2010;
22) REF 225-426. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0740-2010;
23) Stryker CBCII with 3/16 in. Silicone Drain, sterile, REF 0225-028-S16. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0741-2010;
24) Stryker CBCII Collection only pkg/6 with 1/8 in Trocar, sterile, REF 0225-028-S21. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0742-2010;
25) Stryker CBC ConstaVac Blood Conservation Kit 3/16in. (4.8mm) PVC, sterile, REF 225-426-W. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0743-2010
CODE
1) Serial numbers 07303012 through 09173032;
2) Serial numbers 07355012 through 08353012;
3) Serial numbers 07303012 through 09183012;
4) Serial numbers 07306012 through 09163012;
5) Serial numbers 07362012 through 09187012;
6) Serial numbers 08128012 through 09129012;
7) Serial numbers 07303012 through 09104012;
8) Serial numbers 07323012 through 09149012;
9) Serial numbers 07310012 through 09113012;
10) Serial numbers 07311012 through 09183022;
11) Serial numbers 07316012 through 09114012;
12) Serial number 07311012 through 09176012;
13) Serial number 07362012 through 09183012;
14) Serial numbers 07305012 through 09187012;
15) Serial numbers 07310012 through 09159012;
16) Serial numbers 07305012 through 09174012;
17) Serial number 07356012 through 09169012;
18) Serial numbers 07305012 through 09177012;
19) Serial number 07361012 through 09105012;
20) Serial numbers 07318022 through 09189012;
21) Serial number 07305012 through 09168012;
22) Serial number 07304012 through 09178012;
23) Serial number 07317012 through 09192012;
24) Serial numbers 08016012 through 09115012;
25) Serial numbers 07318012 through 09189012;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Medical Div. of Stryker Corp., Portage, MI, by letter dated November 12, 2009.
Manufacturer: Stryker Puerto Rico, LTD, Arroyo, PR. Firm initiated recall is ongoing.
REASON
The product may not be sterile due to package not being intact.
VOLUME OF PRODUCT IN COMMERCE
79,617 units
DISTRIBUTION
Nationwide and Internationally |
