FDA Medical Device Recalls (openFDA)
Integra Neurosciences PR, Inc.: "***REF NL82059-01***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Only***14 g, 3.5"***Plainsboro, NJ***" Needle for lumbar peritoneal shunt
- Recall number
- Z-1048-2012
- Recalling firm
- Integra Neurosciences PR, Inc.
- Product
- "***REF NL82059-01***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Only***14 g, 3.5"***Plainsboro, NJ***" Needle for lumbar peritoneal shunt
- Status
- Terminated
- Initiated
- 2011-11-28
- Posted
- 2012-02-16
- Terminated
- 2013-10-29
- Reason
- The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility.
- Root cause
- Labeling mix-ups
- Action
- Integra sent an Urgent Product Recall Notification letter dated November 28, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fill out and sign the attached Recall Acknowledgement Form noting the part numbers, lot numbers and quantity of the affected product in their inventory. Customers were asked to contact Integra LifeSciences Corporation International Customers Service at 609-936-5400 to arrange for Returns. If customers do not have any of the affected product in their inventory they are required to complete and sign the form and indicate they have NO affected product in their inventory. Customers should fax or email their Recall Acknowledgement Form to: 609-750-4259 or LAPAC_CS@Integralife.com For questions call 609-936-2495.
- Quantity
- 320 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Austria, Canada, Italy, Australia
- Lot, serial or model codes
- 1010046, 1010346, 1010779, 1011037, 1011159, 1011277, 1011590, 1021465, 1030665, 1031019, 1031525, 1070018, 1071032, 1072560, 1073567, 1083958
- 510(k) numbers
- ["K811288","K854049"]
- PMA numbers
- not on file
- Product code
- JXG
- Firm FEI
- 3000204775
- Firm city
- Anasco
- Firm state
- not on file
- Firm country
- PR
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