Device product
Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 units per box: 19 Fr Round Hubless part number 7110; 24 Fr Round Hubless part number 7118. AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system.
Z-1680-2014
Product summary
- Event
- Event 68305
- Status
- Terminated
- Classification
- Class II
- Quantity
- 390
- Official record key
device-enforcement:Z-1680-2014
Official wording
Reason: The recalling firm reported there was inadvertent omission of quarterly (Q4 - 2013 and Q1 - 2014) dose audits/verifications on the affected products. All of the affected products were appropriately sterilized
Code information: 19 Fr Round Hubless part number 7110 lot number 016913; 24 Fr Round Hubless part number 7118 lot numbers 028013, 028113 and 028213..
Distribution pattern: Distributed to one foreign consignee in Lebanon.
Derived failure modes
-
Unknown
The recalling firm reported there was inadvertent omission of quarterly (Q4 - 2013 and Q1 - 2014) dose audits/verifications on the affected products. All of the affected products were appropriately sterilized