Recall Z-0193-2016 ยท FMF Syringe, Piston
Integra LifeSciences Corp. d.b.a. Integra Pain Management
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 Li
| Date | Oct 30, 2015 (initiated Sep 22, 2015) |
| Status | Terminated |
| 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. |
| 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 loca |
| Quantity | A total of 470 packages (47 cases) |
| Distribution | US Distributed to the state of : MD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960248 | GENERAL PROCEDURE KIT Physician Industries, Inc., Apr 12, 1996 |