General Procedure Kit

• • Terminated Z-0193-2016 FDA Class II ·initiated 22 Sep 2015

  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.

• 2 recalls, same reason

  • Terminated Z-2575-2011 FDA Unclassified (pre-2012) ·initiated 19 May 2011
  • Terminated Z-2576-2011 FDA Unclassified (pre-2012) ·initiated 19 May 2011

  Kits contain protective wipes that may be contaminated with Bacillus cereus.

• 29 recalls, same reason

  • Terminated Z-2079-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2105-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2082-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2087-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2104-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2083-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2101-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2097-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2089-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2103-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2095-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2107-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2096-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2098-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2106-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2081-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2100-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2092-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2102-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2108-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2086-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2093-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2090-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2094-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2080-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2085-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2088-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2091-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248
  • Terminated Z-2099-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009 ·on shared 510(k) K960248

  Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.

• • Terminated Z-1635-2008 FDA Unclassified (pre-2012) ·initiated 18 Mar 2008

  Hep-Lock Flush vials included in Integra's PICC Insertion Trays contain a heparin component that has been recalled by Baxter for contaminated heparin.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K960248 ↗

FDA Product Code

FMF

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• General Hygiene Kit

  Class I

  FDA 510(k) K954068 Active Cleared 8 Nov 1995

• Physician Industries' Durameter Syringe

  Class II

  FDA 510(k) K033739 Active Cleared 12 Jul 2004

• Physician Industries Radiofrequency Ablation Needle

  Class II

  FDA 510(k) K040565 Active Cleared 22 Jul 2004