CLASS II Device recall · Reported 27 Aug 2014 · FDA Enforcement Report

CAP Change Kit w/MicroClave Clear recalled by ICU Medical

ICU Medical is recalling CAP Change Kit w/MicroClave Clear, distributed nationwide in the US. The recall was initiated on 5 Aug 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot No. 2704633, 2705206

Quantity recalled300 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2293-2014
FDA event ID: 68973
Recalling firm: ICU Medical, San Clemente, CA
Classification: Class II
Status: Terminated
Recall initiated: 5 Aug 2014
FDA classified: 20 Aug 2014
Reported: 27 Aug 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Syringes & Needles

Timeline

5 Aug 2014	Recall initiated by company
20 Aug 2014	Classified by FDA	+15 days
27 Aug 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.

Where it was distributed

Nationwide Distribution - USA including AL and MD.

Nationwide Alabama Maryland

Questions about this recall

Is CAP Change Kit w/MicroClave Clear recalled?

Yes. ICU Medical recalled CAP Change Kit w/MicroClave Clear on 5 Aug 2014. The recall is Class II and its status is Terminated. Recall number Z-2293-2014.

Why was it recalled?

ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.

Which lots are affected?

Lot No. 2704633, 2705206

Where was it sold?

Nationwide Distribution - USA including AL and MD.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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