CLASS II Device recall · Reported 27 Mar 2013 · FDA Enforcement Report
Sterile Access & Return Line Set, 36" Length, Part # UM recalled
Molded Products is recalling Sterile Access & Return Line Set, 36" Length, Part # UM-872-36, distributed in Michigan. The recall was initiated on 19 Jun 2012 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-0969-2013
- FDA event ID
- 64471
- Recalling firm
- Molded Products, Harlan, IA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Jun 2012
- FDA classified
- 18 Mar 2013
- Reported
- 27 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 19 Jun 2012 | Recall initiated by company | |
| 18 Mar 2013 | Classified by FDA | +272 days |
| 27 Mar 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The recalled product leaks at the connection site.
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
Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.
Where it was distributed
Distributed to one customer in Michigan.
Questions about this recall
Why was it recalled?
The recalled product leaks at the connection site.
Which lots are affected?
Lot numbers: 80106 and 80106b
Where was it sold?
Distributed to one customer in Michigan.
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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