Oscor Medical Sheath Recall Due to Inner Liner Fragmentation During Insertion
Oscor, Inc. is recalling 26 units of the Adelante Breezeway 8F Straight sheath because a fragment of the inner liner detached during insertion. The defect poses a risk of foreign body introduction into the patient.
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 where a fragment detached, posing a risk of harm (foreign body introduction) to patients, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Oscor, Inc. is recalling 26 units of the OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM sheath, Catalog # AB081210. 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 involves specific lots: OR-04691 (Exp. July 16, 2018), C1-11728 (Exp. October 4, 2018), and C1-09375 (Exp. November 5, 2017).
The recall was initiated due to a complaint that during the insertion of the dilator through the sheath, a fragment of the inner liner came out of the sheath prior to use. This defect creates a risk that foreign material could be introduced into the patient's body during the procedure.
The affected units were 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 facilities and distributors should stop using the affected devices and contact Oscor, Inc. for instructions on return or replacement.
The recalled product
- Product
- OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 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
- 26
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 (6)
- Lot #'s: OR-04691 Exp. July 16
- 2018
- C1-11728 Exp. October 4
- C1-09375 Exp. November 5
- 2017 and C1-09375 Exp. November 5
- 2017
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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