FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: 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
- Recall number
- Z-2908-2016
- Recalling firm
- Integra LifeSciences Corp.
- 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
- Status
- Terminated
- Initiated
- 2016-08-23
- Posted
- not on file
- Terminated
- 2017-03-29
- Reason
- During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
- Root cause
- Process control
- Action
- Integra sent an "Urgent Voluntary Medical Device Recall" Letter and Recall Acknowledgement and Return Form dated August 23, 2016 to their affected customer. The letter identified the product, the problem, and the action to be taken by the customer. The customer was advised if they have distributed the product to identify those customers and forward a copy of the enclosed Integra Medical Device Voluntary Recall Notification to those customers. The customer was also asked to review their inventory for the affected product and complete the attached form indicating whether or not they have any of the affected product in their inventory. Customers with questions were instructed to contact Customer Service at 1-800-654-2873.
- Quantity
- 1
- Distribution
- Nationwide Distribution to KS only
- Lot, serial or model codes
- Catalog Number 910122, Lot #0195615 with expiry 04/2019
- 510(k) numbers
- ["K855058"]
- PMA numbers
- not on file
- Product code
- JXG
- Firm FEI
- 3003418325
- Firm city
- Plainsboro
- Firm state
- NJ
- 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