Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PF
FDA device recall Z-1399-2017 · posted 2017-03-03 · Terminated
Recall details
- Recalling firm
- Parker Medical
- Reason for recall
- The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended.
- Action taken
- Parker Medical notified consignees via telephone on December 16, 2016. Consignees were instructed to segregate affected products for immediate pick up. For questions regarding this recall call 239-307-6064.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- CBI
- Quantity affected
- 1,060 units
- Distribution
- Nationwide Distribution to CO, FL, IN, SC and TX. One VA consignee.
- Date initiated
- 2016-12-16
- Date posted
- 2017-03-03
- Date terminated
- 2017-04-17
- Location
- Highlands Ranch, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WELL LEAD ENDOBRONCHIAL TUBES (K092886) | Well Lead Instruments | 2010-03-11 |
| PARKER FLEX-TIP TRACHEAL TUBE (K984528) | Parker Medical Assoc. | 1999-07-15 |