Secure Eva Dual Chamber Mixing Bag

510(k) K960581

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK960581	Date30 Apr 1996Cleared	StatusActive

9 recalls · 8 ongoing · FDA

8 recalls, same reason
- Ongoing Z-0002-2020 FDA Class II initiated 21 Sep 2018
- Ongoing Z-0008-2020 FDA Class II initiated 21 Sep 2018
- Ongoing Z-0005-2020 FDA Class II initiated 21 Sep 2018
- Ongoing Z-0001-2020 FDA Class II initiated 21 Sep 2018
- Ongoing Z-0007-2020 FDA Class II initiated 21 Sep 2018
- Ongoing Z-0003-2020 FDA Class II initiated 21 Sep 2018
- Ongoing Z-0004-2020 FDA Class II initiated 21 Sep 2018
- Ongoing Z-0006-2020 FDA Class II initiated 21 Sep 2018
Potential for leaking product
- Terminated Z-2263-2016 FDA Class II initiated 23 Jun 2016 on shared 510(k) K960581
An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.

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

1 jurisdiction

United States — FDA 510(k) Active

510(k)