Nima Needleless Injectionsite Master Adapter with Posiflow Positive Displacement Feature, and I.V. Sets

510(k) K964918

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

8 closed

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	NumberK964918	Date14 Apr 1997Cleared	StatusActive

8 recalls · FDA

4 recalls, same reason
- Terminated Z-0154-2011 FDA Unclassified (pre-2012) initiated 9 Sep 2010
- Terminated Z-0157-2011 FDA Unclassified (pre-2012) initiated 9 Sep 2010
- Terminated Z-0155-2011 FDA Unclassified (pre-2012) initiated 9 Sep 2010
- Terminated Z-0156-2011 FDA Unclassified (pre-2012) initiated 9 Sep 2010
During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties of the pouch.
2 recalls, same reason
- Terminated Z-0853-05 FDA Unclassified (pre-2012) initiated 3 Mar 2005
- Terminated Z-0854-05 FDA Unclassified (pre-2012) initiated 3 Mar 2005
Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction.
2 recalls, same reason
- Terminated Z-0694-05 FDA Unclassified (pre-2012) initiated 20 Jan 2005
- Terminated Z-0693-05 FDA Unclassified (pre-2012) initiated 20 Jan 2005
Product older than three years may not operate as intended.

1 jurisdiction

United States — FDA 510(k) Active

510(k)