Halo One 5F Introducer Sheath 10 cm 5 pack recall
Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as both…
Why was Halo One 5F Introducer Sheath 10 cm 5 pack recalled?
Complaints of sheath separation, kinking, and/or tip damage during use.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code Lot Number UDI Number Quantity HAL510F 50137866 (01)00801741129698(17)170331(10)50137866 58 HAL510F 50137924 (01)00801741129698(17)170331(10)50137924 73 HAL510F 50138170 (01)00801741129698(17)170331(10)50138170 89 HAL510F 50138765 (01)00801741129698(17)170531(10)50138765 27
- Product
- Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as both…
- Recalling firm
- BARD PERIPHERAL VASCULAR, INC
- Quantity
- 101
- Distribution
- Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH. No foreign distribution.
- Recall date
- January 25, 2017
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)