Z-2522-2015Class II

KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product Code 206); KimVent* Closed...

Name: Z-2522-2015 KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product Code 206); KimVent* Closed...
Creator: Halyard Health, Inc
Published: 2015-07-29
License: https://open.fda.gov/license/

Halyard Health / initiated 2015-07-29 / Terminated / root cause: manufacturing process

FDA source

Halyard Health, Inc began a recall of KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product Code 206); KimVent* Closed Suction System for Neonates/Pediatrics, 8 F, Elbow... on 2015-07-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2522-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-29
Posted: 2015-08-31
Terminated: 2016-01-12
Recalling firm: Halyard Health
Product: KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product Code 206); KimVent* Closed Suction System for Neonates/Pediatrics, 8 F, Elbow (Product Code 208); KimVent* Closed Suction System for Pediatrics, 10 F, Elbow (Product Code 210); KimVent* Closed Suction System for Neonates/Pediatrics, 10 F, Elbow (Product Code 2103); KimVent* Closed Suction Systems for Neonates/Pediatrics, 8 F, Elbow (Product Code 8313); KimVent* Closed Suction System for Neonates/Pediatrics, 8 F, Elbow (Product Code 20083) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
Product code: BSY Catheters, Suction, Tracheobronchial
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.
Root cause tag: manufacturing process
FDA 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
Product codes and lots: Product Code 206 - M5076T503, M5082T501, M5091T504; Product Code 208 - M5089T506, M5096T507, M5103T509; Product Code 210 - M5091T509; Product Code 2103 - M5082T401, M5089T401, M5138T402; Product Code 8313 - M5089T508; Product Code 20083 - M5082T403, M5082T404, M5089T402, M5103T401, M5166T402

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2522-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2492-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2493-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2494-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2495-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2496-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2497-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2498-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2499-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2500-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2501-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2502-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2503-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2504-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2505-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2506-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2507-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2508-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2509-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2510-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2511-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2512-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2513-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2514-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2515-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2516-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2517-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2518-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2519-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2520-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2521-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2522-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31
Z-2523-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31

Product code BSY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)