FDA Medical Device Recalls (openFDA)
Edwards Lifesciences, LLC: Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
- Recall number
- Z-2007-2020
- Recalling firm
- Edwards Lifesciences, LLC
- Product
- Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
- Status
- Terminated
- Initiated
- 2020-03-27
- Posted
- 2020-07-10
- Terminated
- 2021-04-27
- Reason
- Sterile catheter kit packaging compromised.
- Root cause
- Under Investigation by firm
- Action
- Recall is to the customer level. URGENT MEDICAL DEVICE RECALL- ACTION REQUIRED letter, via FedEx, along with an acknowledgment form will be sent to all customers possessing any of the affected units. Letters will be sent overnight via FedEx. Customers will be instructed to acknowledge the notification, contact the firm at the contact information in the communication to obtain a Returned Goods Authorization (RGA) number, and to return all product to the recalling firm.
- Quantity
- 597 units
- Distribution
- US - AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MO, SC, TN, TX and VA.
- Lot, serial or model codes
- Model: XA3816SFKT LOT CODES: 62563142, 62157774, 62132722, 62749306, 62625932
- 510(k) numbers
- ["K172423"]
- PMA numbers
- not on file
- Product code
- DQE
- Firm FEI
- 2015691
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28