Recalls / —
—#149302
Product
Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. External drainag system is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch. One (1) sealed package of lumbar catheter and External drainage system is finally packaged in a cardboard box. Intended for CSF external drainage
- FDA product code
- JXG — Shunt, Central Nervous System And Components
- Device class
- Class 2
- Medical specialty
- Neurology
- 510(k) numbers
- K032817
- Affected lot / code info
- Catalog Number 910120A, Lot #0195870 with expiry 05/2019
Why it was recalled
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Integra LifeSciences Corp.
- Address
- 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344
Distribution
- Distribution pattern
- Nationwide Distribution to KS only
Timeline
- Recall initiated
- 2016-08-23
- Terminated
- 2017-03-29
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #149302. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.