KimVent* Multi-Access Port Replacement Catheter for Adults,Tracheostomy, 14 F (Product Code 2401453-5) A tracheobronchia
FDA device recall Z-2517-2015 · posted 2015-08-31 · Terminated
Recall details
- Recalling firm
- Halyard Health, Inc
- Reason for recall
- The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.
- Action taken
- Halyard sent a Product Advisory Notice on July 29, 2015, via FEDEX with a second letter dated August 12, 2015, being issued via FEDEX. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to report any occurrence of a valve leak to Halyard Customer Service at 1-844-425-9273, option 1, option 3.
- Root cause
- Process control
- Status
- Terminated
- Product code
- BSY
- Distribution
- Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada
- Date initiated
- 2015-07-29
- Date posted
- 2015-08-31
- Date terminated
- 2016-01-12
- Location
- Alpharetta, GA
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