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Recall Observatory FDA recall evidence

Device product

BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL

Z-0756-2013

November 12, 2012

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 64010
Status
Terminated
Classification
Class II
Quantity
2,944,700 units
Official record key
device-enforcement:Z-0756-2013

Official wording

Reason: BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to extended Partial Thromboplastin Time (aPTT) test results reported in two customer complaints.

Code information: Lot No. 2180434; Expiration Date: April 2013

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Canada, India, Japan, Nepal, Malaysia, Singapore, Brazil, Costa Rica, and Virgin Islands.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to extended Partial Thromboplastin Time (aPTT) test results reported in two customer complaints.