Z-1222-2015Class II

KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by...

Name: Z-1222-2015 KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by...
Creator: Halyard Health
Published: 2015-01-16
License: https://open.fda.gov/license/

Halyard Health / initiated 2015-01-16 / Terminated / root cause: packaging

FDA source

Halyard Health began a recall of KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC on 2015-01-16. FDA classified it as Class II and gives the reason as "Defect: A hole or crack was found which may cause air to leak". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1222-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-16
Posted: 2015-02-27
Terminated: 2015-07-07
Recalling firm: Halyard Health
Product: KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
Product code: BSY Catheters, Suction, Tracheobronchial
Reason for recall: Defect: A hole or crack was found which may cause air to leak.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Consignees were notified by letter via FedEx on 01/16/2015.
Quantity in commerce: 83 cases (20 tubes per case)
Distribution: CA, FL, IL, LA, MA, MK, MN, MS, NM, NY, OK and TX and Japan.
Product codes and lots: Product Code; 22108147, Wet Pak Lot number: AB4195U14, AB4216U06 & AB4230U16, KimVent Lot Number: M4132T643.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1222-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1220-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-11	2015-02-27
Z-1221-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-11	2015-02-27
Z-1222-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-11	2015-02-27

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)