Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Co...

FDA Device Recall #Z-0936-2013 — Class II — January 28, 2013

Recall Summary

Recall Number Z-0936-2013
Classification Class II — Moderate risk
Date Initiated January 28, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Bacterin International, Inc.
Location Belgrade, MT
Product Type Devices
Quantity 15 boxes (10/box) to 4 consignees in US and 81 boxes (10/box) to 1 foreign consignee

Product Description

Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage.

Reason for Recall

A portion of a silicone wound drain was found to be cracked.

Distribution Pattern

13 US consignees located in CA, CO, MT, TX, UT, and VA. This represents 4 customers and 9 other individual contacts in USA that received marketing samples. Plus 4 Bacterin representives nationwide received samples. Foreign Consingee

Lot / Code Information

005312; 011012; 012111; 012311; 012511; 013011; 019212; 023611; 023811; 024011; 024211; 025912; 033611; 042211

Other Recalls from Bacterin International, Inc.

Recall # Classification Product Date
Z-1396-2015 Class II Instrument Kit for use with OsteoSponge SC graf... Mar 9, 2015
Z-1680-2014 Class II Wound Drain - Label reads in part "Elutia ***Hu... May 15, 2014
Z-1138-2013 Class II OsteoSelect DBM Putty Product Usage: Ortho... Feb 21, 2013
Z-0800-2013 Class II Bacterin International, Inc., Osteoselect Demin... Apr 18, 2012

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.