Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0936-2013·Announced 2013-03-20

Bacterin Elutia Silicone Surgical Wound Drain Recalled for Cracks

Bacterin International is recalling specific lots of Elutia silicone surgical wound drains because a portion of the drain was found to be cracked.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the defect (cracked silicone) presents a potential risk of harm without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Bacterin International, Inc. is recalling a portion of its Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. The recall was initiated after a portion of a silicone wound drain was found to be cracked. The product is indicated for use in surgical wound drainage.

The affected units are distributed to 13 US consignees located in California, Colorado, Montana, Texas, Utah, and Virginia. This distribution includes 4 customers and 9 other individual contacts in the USA that received marketing samples, plus 4 Bacterin representatives nationwide who received samples. Additionally, 81 boxes were sent to 1 foreign consignee. The specific lot codes affected are 005312, 011012, 012111, 012311, 012511, 013011, 019212, 023611, 023811, 024011, 024211, 025912, 033611, and 042211.

Healthcare providers and consumers should check their inventory for these specific lot codes. If the product is found, it should be removed from use and returned to the distributor or manufacturer for credit or replacement, per standard recall procedures. No specific instructions for end-users are provided in the source text beyond the identification of the defect.

The recalled product

Product: 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.
Manufacturer: Bacterin International, Inc.
Category: Medical Device — Surgical Drain
Hazard: structural-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

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

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Same manufacturer · Bacterin International, Inc.

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