BD Q-Syte Extension Set, 15cm Std Bore, P.V. 1.14 ml… recallZ-0751-2010 · Becton Dickinson Medical Systems · initiated Oct 19, 2009

Why it was recalled

Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.

FDA root cause category: Process control

What the company is doing

Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=

Recall details

Recall number

Z-0751-2010

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Oct 19, 2009

Posted by the FDA

Feb 2, 2010

Recalling firm

Becton Dickinson Medical Systems

Quantity

42,600 units

Product code

FPA

FDA submissions

K013621

Distribution

Nationwide distribution.

Product description

BD Q-Syte Extension Set, 15cm Std Bore, P.V. 1.14 ml Luer-Lok, REF 385101, Becton Dickinson Infusion Therapy Systems Inc.

Other devices under the same FDA submission

5 devices cleared under K013621 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• BD Q-Syte 385100

  Becton, Dickinson And Company · Set, administration, intravascular
  1 death971 reports
• BD Q-Syte 385102

  Becton, Dickinson And Company · Set, administration, intravascular
  269 reports
• BD Q-Syte 385101

  Becton, Dickinson And Company · Set, administration, intravascular
  27 reports
• BD Q-Syte 385108

  Becton, Dickinson And Company · Set, administration, intravascular
  18 reports
• Q-Syte 385103

  Becton, Dickinson And Company · Set, administration, intravascular
  4 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 53749).

• Z-0750-2010 · Terminated
  BD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100, Becton Dickinson Infusion Therapy Systems Inc.
• Z-0752-2010 · Terminated
  BD Q-Syte Extension Set, 15 cm, P.V. 0.21 ml, REF 385102, Becton Dickinson Infusion Therapy Systems Inc.
• Z-0753-2010 · Terminated
  BD Q-Syte Vial Access Adapter, 0.16 ml, REF 385108, Becton Dickinson Infusion Therapy Systems Inc.
• Z-0754-2010 · Terminated
  MPS Acacia Extension Set, 15cm RightBore-18, Spin Nut w/BBD Q-Syte, REF 385150,
• Z-0755-2010 · Terminated
  MPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385151
• Z-0756-2010 · Terminated
  MPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385164