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U.S. Department of Health and Human Services

Class 2 Device Recall Integra Bone Marrow Biopsy Trays

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  Class 2 Device Recall Integra Bone Marrow Biopsy Trays see related information
Date Initiated by Firm September 22, 2015
Date Posted October 30, 2015
Recall Status1 Terminated 3 on January 29, 2016
Recall Number Z-0193-2016
Recall Event ID 72274
510(K)Number K960248  
Product Classification Syringe, piston - Product Code FMF
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.
Code Information There are 3 Integra Lot Numbers affected by the recall of the single lot of Hospira Lidocaine: W1501193, W1504141, W1505078 Catalogue No. 3404253   
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp. d.b.a. Integra Pain Management
3498 West 2400 South #1050
Salt Lake City UT 84119
For Additional Information Contact
801-886-9505
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FMF and Original Applicant = PHYSICIAN INDUSTRIES, INC.
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