Edintrak 4010-O

• FDA 510(k) K940230 decided 12 Dec 1994 Active
• FDA GUDID UDI-DI 07613327362831 listed 30 May 2017 Listed

• 13 recalls, same reason

  • Terminated Z-2414-2019 FDA Class II ·initiated 25 Jul 2019
  • Terminated Z-2421-2019 FDA Class II ·initiated 25 Jul 2019
  • Terminated Z-2413-2019 FDA Class II ·initiated 25 Jul 2019
  • Terminated Z-2420-2019 FDA Class II ·initiated 25 Jul 2019
  • Terminated Z-2416-2019 FDA Class II ·initiated 25 Jul 2019
  • Terminated Z-2412-2019 FDA Class II ·initiated 25 Jul 2019
  • Terminated Z-2418-2019 FDA Class II ·initiated 25 Jul 2019
  • Terminated Z-2419-2019 FDA Class II ·initiated 25 Jul 2019
  • Terminated Z-2417-2019 FDA Class II ·initiated 25 Jul 2019
  • Terminated Z-2423-2019 FDA Class II ·initiated 25 Jul 2019
  • Terminated Z-2415-2019 FDA Class II ·initiated 25 Jul 2019
  • Terminated Z-2422-2019 FDA Class II ·initiated 25 Jul 2019
  • Terminated Z-2424-2019 FDA Class II ·initiated 25 Jul 2019

  The seal integrity of the sterile bag containing the kits may be compromised.

1. 25 Jul 2019 Recall initiated FDA recalls Z-2420-2019
2. 25 Jul 2019 Recall initiated FDA recalls Z-2416-2019
3. 25 Jul 2019 Recall initiated FDA recalls Z-2412-2019
4. 25 Jul 2019 Recall initiated FDA recalls Z-2418-2019
5. 25 Jul 2019 Recall initiated FDA recalls Z-2419-2019
6. 25 Jul 2019 Recall initiated FDA recalls Z-2417-2019
7. 25 Jul 2019 Recall initiated FDA recalls Z-2423-2019
8. 25 Jul 2019 Recall initiated FDA recalls Z-2415-2019
9. 25 Jul 2019 Recall initiated FDA recalls Z-2422-2019
10. 25 Jul 2019 Recall initiated FDA recalls Z-2424-2019

5 earlier events are in the sections above.

Trade name

Edintrak

Generic name

Manual scalpel blade, single-use

Model / Ref / Catalog

4010-O

Primary DI / UDI-DI

07613327362831

510(k) Number

K940230 ↗

FDA product code

HRX

GMDN term

Manual scalpel blade, single-use

Device class

Class II

Regulation number

888.1100

GUDID distribution status

In Commercial Distribution

Sterilisation method

Moist Heat or Steam Sterilization

Category: Manual scalpel blade, single-use

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See all devices from Stryker GmbH →