ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F
Hazard
Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
What You Should Do
Remedy
On 01/17/2017, Technical Bulletin 17.01 was mailed to customers. Customers were informed to clamp all sizes of catheters only in the middle. The following contact information was provided: US: 1-512-474-7278, and Germany: +49-7475-915591.
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Products
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F
- Brand
- OriGen Biomedical, Inc.
- UPC
- Lots: N18446, N18640-1, R19208, R19406
Units Affected
260