ExactaMix EVA Container, 1000mL, REF: 739, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to

FDA device recall Z-1965-2011 · posted 2011-04-12 · Terminated

Recall details

Recalling firm

Baxa Corporation

Reason for recall

TPN bags may leak during filling operation, due to bag manufacturing error.

Action taken

The firm, BAXA, sent a "ExactaMix Bag Product Notice" dated March 8, 2011 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: If they do not intend to use the manual addition port, verify that the cap is firmly seated onto the port by gently tugging on the cap. If they do intend to use the manual addition port, they should snap off the additive port cap prior to compounding the bag. If they encounter a faulty additive port, contact Baxa Technical Support to receive credit and/or replacement on defective product only. To return affected bags, follow the instructions provided in the notice if the bags were purchased directly from Baxa or purchased from wholesaler, distributor or other 3rd party vendor. Additional copies of the return form can be retrieved by going to www.baxa.com/ebug OR by calling Baxa Technical Support at 800-678-2292. If you have any questions or concerns, contact the Sr. Vice President, Quality and Regulatory at (303) 400-2838 or Baxa Technical Support at 800-678-2292.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LHI

Quantity affected

1,088,800 bags

Distribution

Worldwide distribution: USA (nationwide) and countries including: Argentina, Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, Hong Kong, Ireland, Japan, Malaysia, Mexico, New Zealand, Panam

Date initiated

2011-03-08

Date posted

2011-04-12

Date terminated

2012-03-23

Location

Englewood, CO

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