Recall Z-2908-2016— Integra LifeSciences Corp.

Name: FDA recall Z-2908-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-23

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2016-08-23, terminated 2017-03-29. It names one FDA 510(k) clearance: K855058. Product: Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardboard box. Used for Intraoperative drainage of CSF. Reason: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Terminated
Initiated: 2016-08-23
Terminated: 2017-03-29
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K855058 — EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUIDCordis Corp.·cleared 1986-01-10

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 Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardboard box. Used for Intraoperative drainage of CSF

Reason for recall

During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

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