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FDA Medical Device Recalls (openFDA)

Molded Products Inc: Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for connecting hemodialysis blood tubing to the hemodialyzer.

Recall number
Z-1679-2017
Recalling firm
Molded Products Inc
Product
Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for connecting hemodialysis blood tubing to the hemodialyzer.
Status
Terminated
Initiated
2015-01-20
Posted
2017-03-24
Terminated
2017-03-30
Reason
A customer relayed a complaint of a leaking dialysis tubing connector.
Root cause
Process control
Action
On 1/20/2015, the recalling firm requested the firm's customer to return units from the affected lot.
Quantity
400 pieces
Distribution
Product was distributed to Ontario, Canada.
Lot, serial or model codes
40013
510(k) numbers
["K003712"]
PMA numbers
not on file
Product code
KOC
Firm FEI
1000138417
Firm city
Harlan
Firm state
IA
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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