Lifeshield Extension Set

• • Terminated Z-1016-2017 FDA Class II ·initiated 19 Feb 2013

  Hospira, Inc. is voluntarily recalling one lot of list 14699-28, Minibore Extension Set, 59 inch with Spin Lock Collar, Non-DEHP, identified above due to a confirmed customer report of an occlusion of solvent in the male luer lock. This occlusion has the potential to prevent the set from being primed for use and cause a delay in therapy.

• • Terminated Z-1329-2010 FDA Unclassified (pre-2012) ·initiated 24 Nov 2009 ·on shared 510(k) K941214

  Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.

• 4 recalls, same reason

  • Terminated Z-0135-06 FDA Unclassified (pre-2012) ·initiated 29 Sep 2005 ·on shared 510(k) K941214
  • Terminated Z-0134-06 FDA Unclassified (pre-2012) ·initiated 29 Sep 2005 ·on shared 510(k) K941214
  • Terminated Z-0133-06 FDA Unclassified (pre-2012) ·initiated 29 Sep 2005 ·on shared 510(k) K941214
  • Terminated Z-0195-06 FDA Unclassified (pre-2012) ·initiated 6 May 2005 ·on shared 510(k) K941214

  Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.

• 3 recalls, same reason

  • Terminated Z-0956-03 FDA Unclassified (pre-2012) ·initiated 9 Jun 2003 ·on shared 510(k) K941214
  • Terminated Z-0958-03 FDA Unclassified (pre-2012) ·initiated 9 Jun 2003 ·on shared 510(k) K941214
  • Terminated Z-0955-03 FDA Unclassified (pre-2012) ·initiated 9 Jun 2003 ·on shared 510(k) K941214

  The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.

• • Terminated Z-0936-03 FDA Unclassified (pre-2012) ·initiated 13 May 2003 ·on shared 510(k) K941214

  The I.V. administration set incorrectly lists the priming volume from the cassette inlet to distal male adapter as 13.5 mL instead of 11.3 mL

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

510(k) Number

K941214 ↗

FDA Product Code

FPK

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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