Siemens Healthcare Caps for capillary 50/60 uL, Package count 200 For use with blood collection Multicap glass and Multi

FDA device recall Z-1258-2015 · posted 2015-03-06 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics Inc

Reason for recall

Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach and result in breakage of the glass capillary

Action taken

Siemens Healthcare issued an Urgent Field Safety Notice via e-mail to affected Siemens Healthcare Diagnostics Regional offices on January 22, 2015 both in the United States and elsewhere for communication with affected customers. Siemens advises customers to use caution when applying the Capillary Caps with Siemens Multicap glass and Multicap-S plastic capillaries to minimize the potential for breakage or bending.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JKA

Quantity affected

6184

Distribution

Worldwide Distribution. US Nationwide, Australia, Austria, Belgium, Bosnia, Herzegovina, Canada, Colombia, Croatia, Curacao, Czech Republic, Estonia, Finland, France, Georgia, Germany, Great Britain,

Date initiated

2015-01-22

Date posted

2015-03-06

Date terminated

2016-04-13

Location

Norwood, MA