The Recall Desk
HighFDA (Devices)·Z-1258-2015·Announced 2015-03-18

Siemens Healthcare Recalls Capillary Caps Due to Breakage Risk

Siemens Healthcare is recalling capillary caps that may fail to attach, causing glass capillaries to break.

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 involves a risk of harm (glass breakage) where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Siemens Healthcare Diagnostics Inc is recalling Siemens Healthcare Caps for capillary 50/60 uL (SMN: 10328655, Legacy Part number: 478527). The recall involves 6,184 units distributed worldwide, including the United States, Canada, and numerous countries in Europe, Asia, and the Middle East.

The recall was initiated because the caps may not attach properly to the blood collection capillaries. This failure can result in the breakage of the glass capillaries. The affected products are used with Multicap glass and Multicap-S plastic capillaries.

Users of these products should stop using the affected caps and contact Siemens Healthcare Diagnostics Inc for further instructions or a replacement.

The recalled product

Product
Siemens Healthcare Caps for capillary 50/60 uL, Package count 200 For use with blood collection Multicap glass and Multicap-S plastic capillaries SMN: 10328655 Legacy Part number: 478527
Manufacturer
Siemens Healthcare Diagnostics Inc
Category
Medical Device — Blood Collection
Hazard
Affected units
6,184

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)

  • All lot codes

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Siemens Healthcare Diagnostics 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 · Siemens Healthcare Diagnostics Inc

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Same hazard · glass breakage

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