Z-0375-06

Kimberly-Clark/Ballard TRACH CARE Wet Pack * Y Adapter * Closed Suction System for Neonates * Rx Only * 8 Fr...

Name: Z-0375-06 Kimberly-Clark/Ballard TRACH CARE Wet Pack * Y Adapter * Closed Suction System for Neonates * Rx Only * 8 Fr...
Creator: Kimberly-Clark Corporation
Published: 2005-11-30
License: https://open.fda.gov/license/

Kimberly-Clark Corporation / initiated 2005-11-30 / Terminated / root cause: packaging

FDA source

Kimberly-Clark Corporation began a recall of Kimberly-Clark/Ballard TRACH CARE Wet Pack * Y Adapter * Closed Suction System for Neonates * Rx Only * 8 Fr (2.66 mm) * 30.5 cm (12 in) * Single Use *... on 2005-11-30. The reason FDA records is "The integrity of the sterile unit package may become compromised". 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-0375-06
Status: Terminated
Initiated: 2005-11-30
Posted: 2006-01-11
Terminated: 2006-09-06
Recalling firm: Kimberly-Clark Corporation
Product: Kimberly-Clark/Ballard TRACH CARE Wet Pack * Y Adapter * Closed Suction System for Neonates * Rx Only * 8 Fr (2.66 mm) * 30.5 cm (12 in) * Single Use * Manufactured by Ballard Medical Products, Draper, Utah 84020 USA, Distributed in the US by Kimberly-Clark Global Sales, Inc., Roswell, GA 30076 USA
Product code: BSY Catheters, Suction, Tracheobronchial
Reason for recall: The integrity of the sterile unit package may become compromised.
Root cause tag: packaging
FDA root cause: Other
Action: Consignees were notified via certified mail, return receipt on 11/30/2005. The neonatal recall was faxed to the two consignees with a method to return product.
Quantity in commerce: 25 cases (20 units per case)
Distribution: AL, AZ, CA, CO, FL, GA, IA, IL, KY, MD, MO, MN, NJ, NY, OH, OK, PA, RI, SD, TN, TX, UT, VA, WV, WY.
Product codes and lots: Catalog number 8213, Lot Number 309962

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)