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.

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

Recall #: Z-0936-2013
Affected scope: 15 boxes (10/box) to 4 consignees in US and 81 boxes (10/box) to 1 foreign consignee
Initiated: January 28, 2013

Compiled from official public sources by the publisher. · Updated September 2026

Bacterin International, Inc. recalled Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-F… - a moderate-severity action.

Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-F… was recalled by Bacterin International, Inc. in March 20, 2013. Reason: A portion of a silicone wound drain was found to be cracked.. Check the official notice for the remedy. Verify recall #Z-0936-2013 with the FDA Devices before acting.

The recall

Bacterin International, Inc. issued this moderate-severity FDA Devices recall-A portion of a silicone wound drain was found to be cracked..

Moderate
severity level: Class II
classification: March 20, 2013
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0936-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Reason for recall

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

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0936-2013
Date reported	March 20, 2013
Date initiated	January 28, 2013
Recalling firm	Bacterin International, Inc.
Firm location	Belgrade, MT
Affected scope	15 boxes (10/box) to 4 consignees in US and 81 boxes (10/box) to 1 foreign consignee
Distribution	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

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0936-2013) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

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.. Recalled by Bacterin International, Inc.. Units affected: 15 boxes (10/box) to 4 consignees in US and 81 boxes (10/box) to 1 foreign consignee.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on March 20, 2013. Severity: Moderate. Recall number: Z-0936-2013.

Where was the recalled product distributed? ▼

Distribution: 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.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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This recall: FDA Devices, reported March 20, 2013. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026