VersaCross access kits may have a hole in the sterile pouch
VersaCross Access Solution kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.
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: Risk-of-harm product: a compromised sterile barrier on an intravascular access device, with no infection reported in the source.
Plain-English summary
The VersaCross Access Solution (VXSK) is being recalled across the product IDs listed in the recall notice, including VXSK0101, VXSK0102 and VXSK0103. The action covers 14,724 units.
According to the manufacturer, there is a potential for a hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. The manufacturer states the issue could potentially lead to systemic infection and sepsis in a worst case scenario, and that potential punctures may go undetected in clinical settings due to their small size and variable location. The FDA classified the action as Class II. The source does not report any infection having occurred.
Distribution was worldwide, including nationwide in the United States and to Canada and Hong Kong among other markets.
Facilities should identify affected stock using the product IDs, UDI-DI codes and batch numbers in the recall notice and follow the instructions issued by the manufacturer.
The recalled product
- Product
- VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1) VXSK0102 VXSK (180J RF WIRE 63CM/55DEG/D0) VXSK0103 VXSK (180P RF WIRE 63CM/45DEG/D0) VXSK0121 VXSK (180P RF WIRE 63CM/45DEG/D1)
- Manufacturer
- Boston Scientific Corporation
- Hazard
- sterile-barrier
- tyvek-puncture
- infection-risk
- class-ii
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 (18)
- VXSK0025 UDI-DI 00685447011767 Lot 35582041
- VXSK0031 UDI-DI 00685447011828 Lots 35499536 35627156
- VXSK0032 UDI-DI 00685447011835 Lots 35508294 35518904 35563958 35582043 35635451
- VXSK0034 UDI-DI 00685447011859 Lots 35573519 35593310
- VXSK0101 UDI-DI 00685447019749 Lot 35893570
- VXSK0102 UDI-DI 00685447019756 Lot 35720571
- VXSK0103 UDI-DI 00685447019763 Lot 36042383
- VXSK0111 UDI-DI 00685447019794 Lot 35944186
- VXSK0112 UDI-DI 00685447019800 Lot 36061050
- VXSK0121 UDI-DI 00685447019817 Lots 35745702 35787463
- VXSK0123 UDI-DI 00685447019831 Lot 35843757
- VXSK0124 UDI-DI 00685447019848 Lots 35697863 35883199
- VXSK0125 UDI-DI 00685447019855 Lot 35859706
- VXSK0131 UDI-DI 00685447019862 Lots 35729751 35807530 35900608
- VXSK0132 UDI-DI 00685447019879 Lots 35695371 35729750 35807531 35910367 35955008
- VXSK0133 UDI-DI 00685447019886 Lot 35839894
- VXSK0134 UDI-DI 00685447019893 Lot 35666909
- VXSK0137 UDI-DI 00685447019909 Lot 35985522
Distribution
Distributed nationwide across the United States.
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