Empower Introducer Sheath with Hydrophilic Coating 21F recall
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
Why was Empower Introducer Sheath with Hydrophilic Coating 21F recalled?
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
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?
Lot Numbers: PD02, PD00013142 UDI: 00802526618000
- Product
- Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
- Recalling firm
- Freudenberg Medical, Llc
- Quantity
- 8 units (OUS)
- Distribution
- US distribution: GA, OH Foreign distribution: Netherlands
- Recall date
- May 4, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)