RX CHOLANGIOGRAM KIT recalled due to sterile barrier breach
Boston Scientific is recalling RX CHOLANGIOGRAM KIT due to a sterile barrier breach that compromises device sterility. Approximately 500 units distributed worldwide are affected.
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 for compromised sterility on a medical device. While no illnesses or injuries have been reported, the sterile barrier breach presents a risk of harm to users, fitting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Boston Scientific Corporation is recalling RX CHOLANGIOGRAM KIT across eight material numbers (M00575241, M00575281, M00575321, M00575361, M00575381, M00575401, M00575441, M00575481) due to a sterile barrier breach that compromises device sterility. The FDA has classified this as a Class II recall.
Approximately 500 units have been distributed worldwide, including to the United States and to more than 30 countries including Canada, Australia, Japan, Germany, France, and others. Multiple lot numbers for each of the eight material numbers are subject to this recall.
For information regarding this recall, affected parties should contact Boston Scientific Corporation.
The recalled product
- Product
- RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 500
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 (16)
- Lot Numbers: M00575241 RX CHOLANGIOGRAM KIT: Lot Numbers"27879206
- 28103331
- 28336117 UDI: 8714729818380
- M00575281 RX CHOLANGIOGRAM KIT Lot Numbers: 27803953
- 27878151
- 28024443
- 28269925 UDI: 8714729818427
- M00575361 RX CHOLANGIOGRAM KIT Lot Number:28074763 UDI:8714729818458
- M00575381 RX CHOLANGIOGRAM KIT Lot Numbers: 27755939
- 27990502 UDI: 8714729818465
- M00575401 RX CHOLANGIOGRAM KIT Lot NUmber: 28311945 UDI:8714729818472
- M00575441 RX CHOLANGIOGRAM KIT Lot Numbers: 27673853
- 27891176
- 28024444 UDI: 8714729818489
- M00575481 RX CHOLANGIOGRAM KIT Lot Numbers: 27919776
- 28060354 UDI: 8714729818496.
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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