Integra¿ Bone Marrow Biopsy Trays Catalogue No — Class II medical device recall Z-0193-2016
Terminated recall by Integra LifeSciences Corp. d.b.a. Integra Pain Management, reported 2015-11-04. Integra received an Urgent Drug Recall Notice from Hospira Inc. for their 1% Lidocaine HCL Injection, USP, 10
| Recall number | Z-0193-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp. d.b.a. Integra Pain Management, Salt Lake City, UT, United States |
| Recall initiated | 2015-09-22 |
| Classified | 2015-10-29 |
| Reported by FDA | 2015-11-04 |
| Terminated | 2016-01-29 |
| Reason classes | foreign material, specification failure |
| Model numbers | 3404253 |
Product
Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable pouch. Vials of 1 % Lidocaine HCL Injection, USP, 10 mg/mL (manufactured and distributed by Hospira Inc.) are placed in a separate sealed pouch. After the bone marrow biopsy pouch is sterilized, a Lidocaine pouch is affixed to each. Ten of these pouches are inserted in a sealed and labeled corrugated box.
Reason for recall
Integra received an Urgent Drug Recall Notice from Hospira Inc. for their 1% Lidocaine HCL Injection, USP, 10 mg/mL, Lot 44-359-DK. Hospira Inc. is recalling vials of Lot 44-359-DK, 1% Lidocaine HCL Injection, USP, 10 mg/mLm distributed by Hospira from February 2015 to March 2015 due to a confirmed complaint of visible, partially embedded particulate within a single-dose glass teartop vial.
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-0193-2016. 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.