Retiro De Equipo (Recall) de Device Recall Blake Silicone Drain

Recall

58335

Class 2

Z-2756-2011

2011-03-24

2011-07-07

Terminated

United States

2014-01-10

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100045

There is a potential for the sterile barrier to be compromised in multiple lots of blake silicone drains, blake silicone drain kits, blake cardio connectors, j-vac reservoirs, j-vac drain adaptors.

Ethicon, Inc. sent an "URGENT VOLUNTARY PRODUCT RECALL" letter dated March 24& 25, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to discontinue use of the products and to return the products to Stericycle. The letter includes shipping labels for product return. Ethicon will send replacement product. Customers are asked to return a completed Business Reply Card to Stericycle regardless of whether or not they have the products subject to this recall. Customers with questions regarding this recall are directed to call 1-866-664-1401.