Recall Z-2756-2011 ยท KOG
Ethicon, Inc.
Blake Silicone Drain, 1 unit, Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151. Closed Wound Drainage Systems have been used as an adjunct in the following specialties to evacuate potentially detrimental collection of certain fluids (e.g. pus, extravascular blood, bile) from wounds in body cavities and to reduce the risk of infection.
| Date | Jul 7, 2011 (initiated Mar 24, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Packaging process control |
| Action | 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 t |
| Quantity | 846,990 |
| Distribution | Worldwide Distribution-- USA (nationwide) and Puerto Rico and the countries of Armenia, Australia, Austria, Azerbaijan, Columbia, Cyprus, Czech Republic, Denmark, French Guinea, French Polynesian, Germany, Israel, Italy, Japan, Kuwait , Netherlands, New Caledonia, New Zealand, Norway, Singapore, Slo |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953655 | J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS Johnson & Johnson Medical, Inc., Oct 13, 1995 |