Baylis Medical Recalls TorFlex Transseptal Guiding Sheath Kits
Baylis Medical is recalling TorFlex Transseptal Guiding Sheath Kits because the sheath may remove particulate from the dilator, which could migrate into a patient's bloodstream.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sheath could remove particulate of less than 5 mm from the dilator. The particulate could potentially migrate into a patients bloodstream."
Plain-English summary
Baylis Medical Corp is recalling 370 units of the TorFlex Transseptal Guiding Sheath Kits. The product is a single-use device consisting of a sheath, a dilator, and a J-tipped guidewire, designed for catheterization and angiography of specific heart chambers.
The recall is being conducted due to the possibility that the sheath could remove particulate of less than 5 mm from the dilator. This particulate could potentially migrate into a patient's bloodstream.
The affected devices were distributed worldwide, including in the United States (NE, NH, NC, FL, PA, VA, MI, CA, AL, and TN) and in China, Canada, Saudi Arabia, and Italy. The recall covers specific part numbers and lots, including TF8-32-63-135, TF8-32-63-37, TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-81-135, TF8-32-81-37, TF8-32-81-45, TF8-32-81-55, TF8-32-81-90, TF8-38-62-S, TF85-32-63-37, TF85-32-63-45, TF85-32-63-55, TF85-32-63-90, TF85-32-81-135, TF85-32-81-37, and TF85-32-81-90.
The recalled product
- Product
- Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed…
- Manufacturer
- Baylis Medical Corp *
- Hazard
- Affected units
- 370
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 (20)
- Part No. TF8-32-63-135
- Lot TFFB070912
- Part No.TF8-32-63-37
- Lot TFFA310812
- Part. No. TF8-32-63-37
- Lot TFFB290113
- Part No. TF8-32-63-45
- Lot TFFA290113
- Lot TFFB310812
- Lot TFFC221211
- Part No. TF8-32-63-55
- Lot TFFA051212
- Lot TFFA230812
- Lot TFFB221211
- Lot TFFB230113
- Part No. TF8-32-63-90
- Lot TFFA070213
- Lot TFFA070912
- Part No. TF8-32-81-135
- Lot TFFH070912
Distribution
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