Home / Recalls / Bacterin International, Inc. / Z-1680-2014

Z-1680-2014 Class II Terminated

Recalled by Bacterin International, Inc. — Belgrade, MT

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..

Other recalls by Bacterin International, Inc.

  • Z-1396-2015 Class II — Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used t (March 9, 2015)
  • Z-1138-2013 Class II — OsteoSelect DBM Putty Product Usage: Orthopedic bone filler (February 21, 2013)
  • Z-0936-2013 Class II — Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubles (January 28, 2013)
  • Z-0800-2013 Class II — Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; (April 18, 2012)