Integral Lumbar Drainage Set — Class II medical device recall Z-2907-2016
Terminated recall by Integra LifeSciences Corp., reported 2016-10-12, distributed nationwide. During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the
| Recall number | Z-2907-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2016-08-23 |
| Classified | 2016-09-30 |
| Reported by FDA | 2016-10-12 |
| Terminated | 2017-03-29 |
| Distributed | Nationwide (US) |
| Quantity | 18 |
| Reason classes | sterility, packaging |
| Lot numbers | 0195878 |
| Model numbers | 910420 |
| Expiration dates | 2018-10 |
Product
Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. Internal drainage set is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, One (1) sealed package of lumbar catheter and Internal drainage set are finally packed in a cardboard box. Intended for CSF external drainage
Reason for recall
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2907-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.