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Terminated

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

FDA Recall Z-1679-2017 · Posted 2017-03-24

Recalling FirmMolded Products Inc
Recall StatusTerminated
Product CodeKOC
Date Initiated2015-01-20
Date Terminated2017-03-30
Product Quantity400 pieces

Reason for Recall

A customer relayed a complaint of a leaking dialysis tubing connector.

Firm Action

On 1/20/2015, the recalling firm requested the firm's customer to return units from the affected lot.

Root Cause

Process control

Distribution Pattern

Product was distributed to Ontario, Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003712MODIFICATION TO MALE TO MALE LUER ADAPTERMolded Products, Inc. · 2001-05-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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