Skip to content

Mahurkar QPlus Dual Lumen Catheter Kit with Curved… recallZ-0233-04 · Kendall Healthcare Products Co · initiated Dec 2, 2003

Terminated All recalls posted in December 2003

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Kendall Healthcare Products Co or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5Fr x 16.0 cm

FDA root cause category: Other

What the company is doing

Kendall''s recall letters requesting product return will be hand delivered to customers by Kendall sales representatives on December 1, 2003.

Recall details

Recall number
Z-0233-04
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 2, 2003
Posted by the FDA
Dec 17, 2003
Recalling firm
Kendall Healthcare Products Co
Quantity
45 units
Product code
MPB
FDA submissions
K030209
Distribution
IL, MA, OH, TN, TX, VA

Product description

Mahurkar QPlus Dual Lumen Catheter Kit with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion. Reference: 8888-135192

Code information (models, lots, serial numbers)

Lot Number: 140885

Other devices under the same FDA submission

18 devices cleared under K030209 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 27842).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page