Bacterin Elutia Wound Drains Recalled for Missing Dose Audits
Bacterin International is recalling Elutia Hubless Coated Silicone Surgical Wound Drains because quarterly dose audits were omitted. The products were appropriately sterilized.
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. The hazard involves a documentation and process failure (omitted audits) rather than a confirmed physical defect or reported illness, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Bacterin International, Inc. is recalling Elutia Hubless Coated Silicone Surgical Wound Drains. The affected products are available in two sizes: 19 Fr Round Hubless (part number 7110) and 24 Fr Round Hubless (part number 7118). The recall involves 390 units distributed to one foreign consignee in Lebanon. Specific lot numbers affected are 016913 for the 19 Fr size, and 028013, 028113, and 028213 for the 24 Fr size.
The recall was initiated because the firm reported the inadvertent omission of quarterly dose audits and verifications for the fourth quarter of 2013 and the first quarter of 2014. The source text confirms that all affected products were appropriately sterilized.
These devices are intended to be used with an AC-powered or compressed air-powered system to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. Consumers and healthcare providers should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Bacterin International, Inc.
- Affected units
- 390
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 (3)
- 19 Fr Round Hubless part number 7110 lot number 016913
- 24 Fr Round Hubless part number 7118 lot numbers 028013
- 028113 and 028213..
Distribution
Distribution scope not specified by the agency.
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