HYDRATOME RX surgical device recalled due to sterile barrier breach
Boston Scientific recalls 251 HYDRATOME RX 44-30MM/450CM units worldwide due to sterile barrier breach that compromises device sterility.
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: FDA Class II recall for a sterile barrier breach on a medical device. The compromised sterility creates a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for High severity.
Plain-English summary
Boston Scientific Corporation is recalling 251 units of the HYDRATOME RX 44-30MM/450CM surgical device (Material Number: M00583070) due to a sterile barrier breach that compromises device sterility.
The affected units include Lot Numbers Batch 27556713, 27684748, and 27949033 (GTIN: 8714729755227). The devices were distributed worldwide, including throughout the United States and to 36 additional countries.
Healthcare providers and facility managers should stop using affected units immediately and contact Boston Scientific for instructions regarding device return or replacement.
The recalled product
- Product
- HYDRATOME RX 44-30MM/450CM Material Number: M00583070
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Surgical Device
- Hazard
- sterile-barrier-breach
- contamination
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 27556713 27684748 27949033 GTIN: 8714729755227
Distribution
Distributed nationwide across the United States.
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