Exacta-Mix Calibration Bag, Sterile R, non-pyrogenic fluid… recallZ-2145-2010 · Baxa Corporation · initiated May 26, 2010

Why it was recalled

Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.

FDA root cause category: Process design

What the company is doing

Consignees were notified by e-mail and Baxa Bag Product Notice letter on 05/26/2010 with instructions to not use any bags if the fill port cap is detached. Photos of a detached cap and properly attached cap were included. Defective bags could be returned to Baxa for credit. Information available at 800-678-2292.

Recall details

Recall number

Z-2145-2010

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

May 26, 2010

Posted by the FDA

Aug 2, 2010

Recalling firm

Baxa Corporation

Quantity

7,450 bags

Product code

KPE

FDA submissions

K900585

Distribution

Worldwide distribution, including USA, Argentina, Australia, Bermuda, Brazil, Canada, China, Colombia, Hong Kong, Malaysia, Mexico, New Zealand, Pakistan, Panama, South Korea, Taiwan, United Kingdom, and Uruguay.

Product description

Exacta-Mix Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL Reorder No. H938 371 3, Manufactured for Baxa Corporation.

Other devices under the same FDA submission

8 devices cleared under K900585 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• EXACTAMIX H938740

  Baxter Healthcare Corporation · Set, i.V. Fluid transfer
  1 recall1,350 reports
• EXACTAMIX H938738

  Baxter Healthcare Corporation · Set, i.V. Fluid transfer
  1 recall1,180 reports
• EXACTAMIX H938739

  Baxter Healthcare Corporation · Set, i.V. Fluid transfer
  1 recall972 reports
• EXACTAMIX H938741

  Baxter Healthcare Corporation · Set, i.V. Fluid transfer
  1 recall710 reports
• EXACTAMIX H938737

  Baxter Healthcare Corporation · Set, i.V. Fluid transfer
  1 recall607 reports
• EXACTAMIX H938742

  Baxter Healthcare Corporation · Set, i.V. Fluid transfer
  93 reports
• EXACTAMIX H938743

  Baxter Healthcare Corporation · Set, i.V. Fluid transfer
  87 reports
• EXACTAMIX H938735

  Baxter Healthcare Corporation · Set, i.V. Fluid transfer
  1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 55931).

• Z-2137-2010 · Terminated
  Exacta-Mix EVA Container, Sterile R, 250 mL, Order No. REF: 137, Baxa Corporation.
• Z-2138-2010 · Terminated
  Exacta-Mix EVA Container, Sterile R, 500 mL, Order No. REF: 138, Baxa Corporation.
• Z-2139-2010 · Terminated
  Exacta-Mix EVA Container, Sterile R, 1000 mL, Order No. REF: 139, Baxa Corporation.
• Z-2140-2010 · Terminated
  Exacta-Mix EVA Container, Sterile R, 2000 mL, Order No. REF: 140, Baxa Corporation.
• Z-2141-2010 · Terminated
  Exacta-Mix EVA Container, Sterile R, 3000 mL, Order No. REF: 141, Baxa Corporation.
• Z-2142-2010 · Terminated
  Exacta-Mix EVA Container, Sterile R, 4000 mL, Order No. REF: 142, Baxa Corporation.
• Z-2143-2010 · Terminated
  Exacta-Mix EVA Container, Sterile R, 5000 mL, Order No. REF: 143, Baxa Corporation.
• Z-2144-2010 · Terminated
  Halobag EVA Dual-Chamber Bag, Sterile R, 3000 mL Total Volume W/500 mL upper chamber, Order No. REF: 341, Baxa Corporation.
• Z-2146-2010 · Terminated
  Exacta-Mix 2400 Valve Assembly w/Calibration Bag, Sterile R, 250 mL, Order No. REF: 724, Baxa Corporation.
• Z-2147-2010 · Terminated
  Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembled, Tubing Kit w/Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL, Order No. REF 706, Baxa Corporation.
• Z-2148-2010 · Terminated
  Exacta - Mix Valve Set, Six Inlet, Tubing Kit w/Calibration Bag, Fluid Path is sterile and non-pyrogenic in unopened, undamaged package, 250 mL, Order No. REF: 706D, Baxa Corporat…