Oscor Medical Sheath Recall Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 76 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 medical device defect (fragmentation) that poses a risk of harm during a procedure, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Oscor, Inc. is recalling 76 units of the OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM sheath, Catalog # AB081045. 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 units are 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, Netherlands, Egypt, Germany, Hong Kong, Israel, Italy, Switzerland, and Vietnam.
Healthcare providers should stop using the affected lots immediately. The specific lot numbers involved are C1-09374, C1-10319, C1-11202, C1-11671, and C1-11672, with expiration dates ranging from November 5, 2017, to September 30, 2018.
The recalled product
- Product
- OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM Catalog # AB081045 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
- 76
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 (8)
- Lot #'s: C1-09374 Exp. November 5
- 2017
- C1-10319 Exp. May 11
- 2018
- C1-11202 Exp. August 24
- C1-11671 Exp. September 30
- C1-11672 Exp. September 30
- and C1-09374 Exp. November 5
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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