CLASS II Device recall · Reported 5 Apr 2017 · FDA Enforcement Report
Non-Sterile Double DIN to DIN "Y" Connector recalled by Molded Products
Molded Products is recalling Non-Sterile Double DIN to DIN "Y" Connector. The recall was initiated on 20 Jan 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1679-2017
- FDA event ID
- 76760
- Recalling firm
- Molded Products, Harlan, IA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Jan 2015
- FDA classified
- 24 Mar 2017
- Reported
- 5 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 20 Jan 2015 | Recall initiated by company | |
| 24 Mar 2017 | Classified by FDA | +794 days |
| 5 Apr 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A customer relayed a complaint of a leaking dialysis tubing connector.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for connecting hemodialysis blood tubing to the hemodialyzer.
Where it was distributed
Product was distributed to Ontario, Canada.
Questions about this recall
Why was it recalled?
A customer relayed a complaint of a leaking dialysis tubing connector.
Which lots are affected?
40013
Where was it sold?
Product was distributed to Ontario, Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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