Biocardia Recalls Morph Accesspro Steerable Introducers Due to Packaging Wear
Biocardia is recalling 11 units of Morph Accesspro Steerable Introducers because worn Tyvek packaging may cause loss of package integrity.
What this means for you
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 hazard involves a potential loss of package integrity without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Biocardia, Inc. is recalling 11 units of the MORPH ACCESSPRO Steerable Introducer, catalog number MAP690. The affected units are 6F introducers with a 90 cm working length, sterilized by EtO gas and non-pyrogenic. The specific lot numbers involved are 01162 and 01186.
The recall is being conducted because the Tyvek packaging may be worn, which can cause a loss of package integrity. This defect could potentially compromise the sterile barrier of the medical device.
The affected products were distributed in the United States, specifically in the states of Florida, Massachusetts, Wyoming, Ohio, Michigan, and Kansas. Healthcare providers and facilities that have received these specific units should stop using them and contact Biocardia, Inc. for instructions on return or replacement.
The recalled product
- Product
- MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia Inc. San Carlos, CA 94070 Intended to provide a pathway through which medical instruments such as balloon dilati
- Manufacturer
- Biocardia, Inc.
- Category
- Medical Device — Introducer
- Hazard
- Affected units
- 11
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 (2)
- Catalog number MAP690
- Lot numbers 01162 and 01186.
Distribution
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