The Recall Desk
HighFDA (Devices)·Z-1256-2015·Announced 2015-03-18

Siemens Healthcare Recalls Capillary Caps Due to Breakage Risk

Siemens Healthcare is recalling capillary caps for RAPIDLyte blood collection devices because they may not attach properly, 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 medical device where a mechanical failure (cap detachment) leads to glass breakage, posing a risk of injury (cuts/shards) to patients or staff. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Siemens Healthcare Diagnostics Inc is recalling Siemens Healthcare Caps for capillary 100 uL (SMN: 10311053, Legacy Part number: 478601). The recall involves 10,741 units distributed worldwide, including the United States, Canada, Australia, and numerous countries in Europe, Asia, and the Middle East.

The recall was initiated because the caps may not attach securely to the RAPIDLyte Multicap and Multicap-S blood collection capillaries. This failure can result in the breakage of the glass capillary. The recall covers all lot codes for this specific product.

Healthcare facilities and consumers who have these caps should stop using them and contact Siemens Healthcare Diagnostics Inc for instructions on return or replacement. The product is intended for use with blood collection Multicap glass and Multicap-S plastic capillaries.

The recalled product

Product
Siemens Healthcare Caps for capillary 100 uL , Package count 200 For use with blood collection Multicap glass and Multicap-S plastic capillaries SMN: 10311053 Legacy Part number: 478601
Manufacturer
Siemens Healthcare Diagnostics Inc
Category
Medical Device — Blood Collection Accessories
Hazard
Affected units
10,741

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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