Baxter Interlink System Minivolume Extension Set, product… recallZ-0638-06 · Baxter Healthcare Corp. · initiated Dec 15, 2005

Why it was recalled

The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.

FDA root cause category: Other

What the company is doing

Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include additional lots and product codes via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.

Recall details

Recall number

Z-0638-06

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Dec 15, 2005

Posted by the FDA

Mar 24, 2006

Recalling firm

Baxter Healthcare Corp.

Quantity

7,488 sets

Product code

FPA

FDA submissions

K925126

Distribution

Nationwide, including Puerto Rico and American Samoa, and internationally to Canada, Australia, Japan, South Korea, Saudi Arabia, India, Mexico, Venezuela, Malaysia, East Timor and New Zealand.

Product description

Baxter Interlink System Minivolume Extension Set, product code 1C8378; An Rx sterile, nonpyrogenic fluid pathway, 9.0'', 0.6 mL Vol., with injection site and male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

Other devices under the same FDA submission

4 devices cleared under K925126 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• INTERLINK 2N3374

  Baxter International Inc. · Set, administration, intravascular
  7 reports
• INTERLINK 2N3378

  Baxter International Inc. · Set, administration, intravascular
  7 reports
• INTERLINK 2N3379

  Baxter Healthcare Corporation · Set, administration, intravascular
  6 reports
• INTERLINK 2N3399

  Baxter Healthcare Corporation · Set, administration, intravascular
  2 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 34290).

• Z-0626-06 · Terminated
  Baxter Non-DEHP Y-Type Catheter Extension Set, product code 2N1191; An Rx sterile, nonpyrogenic fluid pathway, 4.8', 0.6 mL Vol., with male Luer Lock adapter; Baxter Healthcare Cor…
• Z-0629-06 · Terminated
  Baxter Interlink System Non-DEHP Standard Bore 3-Lead Catheter Extension Set, product code 2N3335; An Rx sterile, nonpyrogenic fluid pathway with 2 Interlink injection sites and a …
• Z-0630-06 · Terminated
  Baxter Interlink System T-Connector Extension Set, product code 2N3343; An Rx sterile, nonpyrogenic fluid pathway, 7.0'', 1.0 mL Vol., with 1 Interlink T-connector injection sites…
• Z-0634-06 · Terminated
  Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, product code 2N3384; An Rx sterile, nonpyrogenic fluid pathway, 9.0'', 0.5 mL Vol., with injection site and male Luer …
• Z-0637-06 · Terminated
  Baxter Interlink System Minivolume Extension Set, product code 1C8290; An Rx sterile, nonpyrogenic fluid pathway, 11.0'', 0.86 mL Vol., with 2 injection sites and male Luer Lock ad…
• Z-0640-06 · Terminated
  Baxter Interlink System Minivolume Extension Set, product code 1C8412; An Rx sterile, nonpyrogenic fluid pathway, 16.0'', 1.0 mL Vol., with injection site, 0.22 Micron Downstream F…
• Z-0641-06 · Terminated
  Baxter Interlink System Minivolume Extension Set, product code 1C8462; An Rx sterile, nonpyrogenic fluid pathway, 16.0'', 4.2 mL Vol., with 2 injection sites, 0.22 Micron Downstrea…
• Z-0643-06 · Terminated
  Baxter Interlink System Minivolume Extension Set, product code 1C8590; An Rx sterile, nonpyrogenic fluid pathway, 22'', 0.9 mL Vol, with injection site and Stationary Swivel Lock T…
• Z-0644-06 · Terminated
  Baxter Interlink System Minivolume Extension Set, product code 1C8643; An Rx sterile, nonpyrogenic fluid pathway, 7'', 0.3 mL Vol, with Male Luer Slip T-Connector; Baxter Healthcar…
• Z-0646-06 · Terminated
  Baxter Interlink System Extension Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0071; An Rx sterile, nonpyrogenic fluid …
• Z-0648-06 · Terminated
  Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8645; An Rx sterile, nonpyrogenic fluid pathway, 9.0'', 0.8 mL Vol., with 2 injection sites and male Luer Lo…
• Z-0652-06 · Terminated
  Baxter Interlink System Minivolume Extension Set, product code 1C8740; An Rx sterile, nonpyrogenic fluid pathway, 16.0'', 1.0 mL Vol., with injection site, 0.22 Micron Downstream F…
• Z-0653-06 · Terminated
  Baxter Interlink System Continu-Flo Solution Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0078; An Rx sterile, nonpyrog…
• Z-0654-06 · Terminated
  Baxter Interlink System Buretrol Solution Set with Large Bore 3-Way Stopcock with Rotating Male Luer Lock Extension Set and Minivolume Extension Set, product code 3C0108; An Rx ste…
• Z-0656-06 · Terminated
  Baxter Interlink System Buretrol Solution Set with Large Bore 4-Way Stopcock with Rotating Male Luer Lock Extension Set and Extension Set, product code 3C0172; An Rx sterile, nonp…