Z-1680-2014 Class II Terminated
FDA device recall Z-1680-2014 was initiated by Bacterin International, Inc. on May 15, 2014 and is designated Class II. Reason for recall: 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 s… The recall status is terminated (terminated June 2, 2014). Affected quantity: 390.
Recall Details
- Product Type
- Devices
- Report Date
- June 11, 2014
- Initiation Date
- May 15, 2014
- Termination Date
- June 2, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 390
Product Description
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.
Reason for Recall
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
Distribution Pattern
Distributed to one foreign consignee in Lebanon.
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..