The Recall Desk
HighFDA (Devices)·Z-2294-2014·Announced 2014-08-27

ICU Medical Recalls BD PosiFlush Syringes Due to Open Seals

ICU Medical is recalling BD PosiFlush Sterile Field Saline Flush Syringes because some packages may have open seals, potentially compromising sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential loss of sterility in a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe. The recall is being conducted because some unit packages may exhibit open seals. This defect impacts package sterility and potentially product sterility.

The affected product is the Cap Change Kit with MicroClave Clear Connector, Item No. B79103. 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. The specific lot number involved is 2705219.

The recall involves 300 units that were distributed nationwide in the USA, including Alabama and Maryland. No specific instructions for consumers are provided in the source text beyond the identification of the affected lot.

The recalled product

Product
Cap Change Kit with MicroClave Clear Connector, Item No. B79103 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.
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Syringes
Hazard
Affected units
300

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot No. 2705219

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 3 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · ICU Medical, Inc.

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Same hazard · sterility compromise

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