Recall Z-0193-2016— Integra LifeSciences Corp. d.b.a. Integra Pain Management

Name: FDA recall Z-0193-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-22

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp. d.b.a. Integra Pain Management, initiated 2015-09-22, terminated 2016-01-29. It names one FDA 510(k) clearance: K960248. 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: 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..

Recalling firm: Integra LifeSciences Corp. d.b.a. Integra Pain Management
Classification: Class II
Status: Terminated
Initiated: 2015-09-22
Terminated: 2016-01-29
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K960248 — GENERAL PROCEDURE KITPhysician Industries, Inc.·cleared 1996-04-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.