Device 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
Z-2910-2016
Product summary
- Event
- Event 75065
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-2910-2016
Official wording
Reason: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Code information: Catalog Number 910120A, Lot #0195870 with expiry 05/2019
Distribution pattern: Nationwide Distribution to KS only
Derived failure modes
-
Labeling or packaging
incomplete packaging