Z-0193-2016Class II

Integra Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform...

Name: Z-0193-2016 Integra Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform...
Creator: Integra LifeSciences Corp. d.b.a. Integra Pain Management
Published: 2015-09-22
License: https://open.fda.gov/license/

Integra Pain Management / initiated 2015-09-22 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. d.b.a. Integra Pain Management began a recall of 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... on 2015-09-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0193-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-22
Posted: 2015-10-30
Terminated: 2016-01-29
Recalling firm: Integra Pain Management
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.
Product code: FMF Syringe, Piston
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Integra sent an Urgent Medical Device / Drug Recall Notice dated September 22, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed.to forward copies of the Integra and Hospira recall notification letters to their customers. Confirmation of recall notification delivery and instructed to stop use of devices and return to Integra. If you have questions of a customer service nature or beyond the information in the Hospira Inc. URGENT DRUG PRODUCT RECALL NOTICE, please contact either your local Integra Pain Management Sales Representative or customer service at 1-800-241-2210.
Quantity in commerce: A total of 470 packages (47 cases)
Distribution: US Distributed to the state of : MD.
Product codes and lots: There are 3 Integra Lot Numbers affected by the recall of the single lot of Hospira Lidocaine: W1501193, W1504141, W1505078 Catalogue No. 3404253

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0193-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0193-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-04	2015-10-29

Product code FMF

K960248Class IIGeneral Procedure KitPhysician Industries, Inc. / cleared 1996-04-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)