Recall Z-2520-2015 ยท BSY Catheters, Suction, Tracheobronchial
Halyard Health, Inc
KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Y-Adapter (Product Code 195); KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Y-Adapter (Product Code 196); KimVent* Closed Suction System for Neonates/Pediatrics, 7 F, Y-Adapter (Product Code 197); KimVent* Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapter (Product Code 198); KimVent* Closed Suction System for N
| Date | Aug 31, 2015 (initiated Jul 29, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Distribution | Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.