FDA Medical Device Recalls (openFDA)
Halyard Health: KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
- Recall number
- Z-1222-2015
- 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.
- Status
- Terminated
- Initiated
- 2015-01-16
- Posted
- 2015-02-27
- Terminated
- 2015-07-07
- Reason
- Defect: A hole or crack was found which may cause air to leak.
- Root cause
- Packaging process control
- Action
- Consignees were notified by letter via FedEx on 01/16/2015.
- Quantity
- 83 cases (20 tubes per case)
- Distribution
- CA, FL, IL, LA, MA, MK, MN, MS, NM, NY, OK and TX and Japan.
- Lot, serial or model codes
- Product Code; 22108147, Wet Pak Lot number: AB4195U14, AB4216U06 & AB4230U16, KimVent Lot Number: M4132T643.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BSY
- Firm FEI
- 3011157493
- Firm city
- Roswell
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28