Hydratome RX 44-20MM medical device recalled for sterile barrier breach
Boston Scientific is recalling 254 units of the Hydratome RX 44-20MM medical device worldwide due to a compromised sterile barrier that may affect device sterility.
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 3/5 (High).
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: This is an FDA Class II recall involving a confirmed sterile barrier breach on a medical device. While the compromised sterility poses a potential risk of contamination, no illnesses or injuries have been reported in the source material.
Plain-English summary
Boston Scientific Corporation is recalling 254 units of the Hydratome RX 44-20MM medical device (Material Number M00583060). The device was distributed worldwide, including throughout the United States and to numerous countries including Australia, Austria, Belgium, Canada, China, France, Germany, Japan, Korea, and others.
The recall is due to a compromised sterile barrier on the device. The sterile barrier breach may result in loss of device sterility, creating a potential risk if the device is used. This is classified as an FDA Class II recall.
The affected units are identified by lot numbers Batch 27442309 and Batch 28020415 (GTIN 8714729755210).
The recalled product
- Product
- HYDRATOME RX 44-20MM/450CM Material Number: M00583060
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Affected units
- 254
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 (1)
- Lot Numbers: Batch 27442309 28020415 GTIN: 8714729755210
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 31 recalled by Boston Scientific Corporation 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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