Oscor Medical Sheath Recall Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 20 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a structural defect in a medical device used for cardiac procedures where a fragment detached, posing a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Oscor, Inc. is recalling 20 units of the OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM sheath, Catalog # AB10218. This medical device is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
The recall was initiated after a complaint reported that a fragment of the inner liner came out of the sheath prior to use during the insertion of the dilator. The affected lots are C1-11201, C1-11200, and C1-11873, with expiration dates in August and October 2018.
The product was distributed worldwide, including in the United States (California, New Jersey, Maryland, Texas, Florida, North Carolina, Missouri, and Puerto Rico) and internationally to Austria, Bolivia, Canada, Chile, Cyprus, the Netherlands, Egypt, Germany, Hong Kong, Israel, Italy, Switzerland, and Vietnam. Healthcare providers and facilities should stop using the affected devices and contact Oscor, Inc. for instructions on return or replacement.
The recalled product
- Product
- OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
- Manufacturer
- Oscor, Inc.
- Affected units
- 20
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 (4)
- Lot #'s: C1-11201 Exp. August 23
- 2018
- C1-11200 Exp. August 23
- and C1-11873 Exp. October 21
Distribution
Part of a larger recall action
This product is one of 30 recalled by Oscor, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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