Microtek 1

• FDA 510(k) K001082 decided 15 Jun 2000 Active
• FDA GUDID UDI-DI 00748426100866 listed 4 Nov 2016 Listed

• 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.

1. 10 Mar 2015 Recall initiated FDA recalls Z-1346-2015
2. 10 Mar 2015 Recall initiated FDA recalls Z-1343-2015
3. 10 Mar 2015 Recall initiated FDA recalls Z-1340-2015
4. 10 Mar 2015 Recall initiated FDA recalls Z-1344-2015
5. 10 Mar 2015 Recall initiated FDA recalls Z-1345-2015
6. 10 Mar 2015 Recall initiated FDA recalls Z-1342-2015
7. 10 Mar 2015 Recall initiated FDA recalls Z-1341-2015
8. 10 Mar 2015 Recall initiated FDA recalls Z-1348-2015
9. 10 Mar 2015 Recall initiated FDA recalls Z-1337-2015
10. 4 Nov 2016 Listed FDA GUDID 00748426100866

6 earlier events are in the sections above.

Trade name

Microtek

Generic name

Surgical fluid/smoke waste management system suction unit

Model / reference

1

Primary DI / UDI-DI

00748426100866

510(k) Number

K001082 ↗

FDA product code

FYD

GMDN term

Surgical fluid/smoke waste management system suction unit

Device class

Class II

Regulation number

878.5070

GUDID distribution status

In Commercial Distribution

Category: Surgical fluid/smoke waste management system suction unit

Other devices filed under FDA product code FYD (APPARATUS, EXHAUST, SURGICAL).

• BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801 by Buffalo Filter Co., Inc.
• I/A Tubing ICM-000-0003 by I.C. Medical, Inc.
• VISICLEAR SMOKE EVACUATION SYSTEM by Buffalo Filter Co., Inc.
• SMOKE EVACUATION HOSES/TUBING by Dm Medical, Inc.
• Medline Smoke Evacuation Shroud by MEDLINE INDUSTRIES, INC.
• FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC by Utah Medical Products, Inc.
• PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1 by Pall Medical
• I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATOR by I.C. Medical, Inc.
• BOWA 952-100 by Conmed Corporation
• SMOKE EATER by Nordex Medical Corp.

• Medline-Microtek Probe Covers

  Class II

  GUDID on market

• Procept BioRobotics

  Class I

  CE/MDR GUDID on market

• Medline-Microtek Decanters Open recall

  Class II

  FDA 510(k) K811233 Active Cleared 17 Jun 1981 GUDID on market

• CareFusion Patient Drapes

  Class II

  GUDID on market

See all devices from Microtek Medical LLC →