Oscor Breezeway Sheath Recalled Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 255 Breezeway sheaths because a fragment of the inner liner detached during insertion, posing a risk of injury.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a physical fragment detaching during a cardiac procedure, which constitutes a significant injury risk.
Plain-English summary
Oscor, Inc. is recalling 255 units of the OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP sheath (Catalog # AB1061FT). The device is designed to facilitate the introduction of catheters to 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. This defect presents a risk of injury to patients during the procedure.
The affected units are from Lot # C1-08260 (Expiration: October 6, 2016) and Lot # C1-08283 (Expiration: October 14, 2016). The products were distributed worldwide, including in the United States (CA, NJ, MD, TX, FL, NC, MO, 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 these devices and contact Oscor, Inc. for further instructions.
The recalled product
- Product
- OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT 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.
- Hazard
- Affected units
- 255
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)
- Lot #'s: C1-08260 Exp. October 6
- 2016 and C1-08283 October 14
- 2016
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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