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FDA Medical Device Recalls (openFDA)

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

Recall number
Z-0233-04
Recalling firm
Kendall Healthcare Products Co
Product
Mahurkar QPlus Dual Lumen Catheter Kit with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion. Reference: 8888-135192
Status
Terminated
Initiated
2003-12-02
Posted
2003-12-17
Terminated
2012-05-15
Reason
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
Root cause
Other
Action
Kendall''s recall letters requesting product return will be hand delivered to customers by Kendall sales representatives on December 1, 2003.
Quantity
45 units
Distribution
IL, MA, OH, TN, TX, VA
Lot, serial or model codes
Lot Number: 140885
510(k) numbers
["K030209"]
PMA numbers
not on file
Product code
MPB
Firm FEI
1282497
Firm city
Mansfield
Firm state
MA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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