Recall Z-2624-2014— Integra York PA, Inc

Name: FDA recall Z-2624-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-30

Class II · Terminated

Class II FDA medical device recall by Integra York PA, Inc, initiated 2014-07-30, terminated 2015-03-10. It names 2 FDA 510(k) clearances: K112090, K102146. Product: Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Gold; Container Lid, ¿¿ Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524, 730621, 730622 The Integra Sterilization Container is intended for use in hospitals and healthcare facilities to contain other medical devices that are to be steam sterilized (autoclaved) by the facility prior to use. Sterilized devices may be stored and transferred within the facility in the container per the healthcare facilities protocols. Integra provides these items to users as either as a tray and lid combination, just a tray, or just a lid.. Reason: Integra LifeSciences has identified through an internal investigation that some colored lids for Integra container systems were not yet cleared by the FDA for sale and were inadvertently distributed..

Recalling firm: Integra York PA, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-07-30
Terminated: 2015-03-10
Firm location: York, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K112090 — BAHADIR STERILIZATION TRAYSBahadir USA Corp.·cleared 2012-06-07
K102146 — BAHADIR STERILIZATION TRAYSBahadir USA Corp.·cleared 2010-11-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Gold; Container Lid, ¿¿ Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524, 730621, 730622 The Integra Sterilization Container is intended for use in hospitals and healthcare facilities to contain other medical devices that are to be steam sterilized (autoclaved) by the facility prior to use. Sterilized devices may be stored and transferred within the facility in the container per the healthcare facilities protocols. Integra provides these items to users as either as a tray and lid combination, just a tray, or just a lid.

Reason for recall

Integra LifeSciences has identified through an internal investigation that some colored lids for Integra container systems were not yet cleared by the FDA for sale and were inadvertently distributed.

Data sourced from openFDA. This site is unofficial and independent of the FDA.