Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi
FDA device recall Z-1928-2020 · posted 2020-05-08 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences, LLC
- Reason for recall
- Intermittent communication due to inconsistent crimping of connectors onto cables.
- Action taken
- On xx/xx/2019, and URGENT MEDICAL DEVICE RECALL-ACTION REQUIRED, letter was sent to customers by FedEx. Customers are instructed to acknowledge this 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 recalling firm.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQK
- Quantity affected
- 35
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, CA, FL, IL, IN and MO, and the countries of Germany, Netherlands, United Kingdom.
- Date initiated
- 2019-10-07
- Date posted
- 2020-05-08
- Date terminated
- 2021-04-27
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable (K163381) | Edwards Lifesciences, LLC | 2017-04-14 |