Stackhouse Smoke Evacuator, Models St-3000, St 3100

• 13 recalls, same reason

  • Terminated Z-1347-2015 FDA Class II ·initiated 10 Mar 2015
  • Terminated Z-1338-2015 FDA Class II ·initiated 10 Mar 2015 ·on shared 510(k) K001082
  • Terminated Z-1339-2015 FDA Class II ·initiated 10 Mar 2015 ·on shared 510(k) K001082
  • Terminated Z-1349-2015 FDA Class II ·initiated 10 Mar 2015
  • Terminated Z-1346-2015 FDA Class II ·initiated 10 Mar 2015
  • Terminated Z-1343-2015 FDA Class II ·initiated 10 Mar 2015
  • Terminated Z-1340-2015 FDA Class II ·initiated 10 Mar 2015 ·on shared 510(k) K001082
  • Terminated Z-1344-2015 FDA Class II ·initiated 10 Mar 2015
  • Terminated Z-1345-2015 FDA Class II ·initiated 10 Mar 2015
  • Terminated Z-1342-2015 FDA Class II ·initiated 10 Mar 2015
  • Terminated Z-1341-2015 FDA Class II ·initiated 10 Mar 2015
  • Terminated Z-1348-2015 FDA Class II ·initiated 10 Mar 2015
  • Terminated Z-1337-2015 FDA Class II ·initiated 10 Mar 2015 ·on shared 510(k) K001082

  This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

• • Terminated Z-2109-2010 FDA Unclassified (pre-2012) ·initiated 25 May 2010

  Product labeled as sterile was distributed without sterilization.

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

510(k) Number

K001082 ↗

FDA Product Code

FYD

Device Class

Class II

Regulation

21 CFR Part 878.5070

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Stackhouse Lens Hood, Model SA-700/Fs

  Class II

  FDA 510(k) K003194 Active Cleared 26 Oct 2000

• Stackhouse Lens Hood, Model SA-700/F

  Class II

  FDA 510(k) K000605 Active Cleared 17 Aug 2000

• Freedom Aspirator, Model 6000

  Class II

  FDA 510(k) K944116 Active Cleared 7 Sep 1994