CLASS II Device recall · Reported 16 Mar 2016 · FDA Enforcement Report
Custom Assembly, Custom Fcffm x/ Tubing Extension recalled
Value Plastics is recalling Custom Assembly, Custom Fcffm x/ Tubing Extension, distributed in Minnesota, New York, Pennsylvania, Virginia. The recall was initiated on 18 Dec 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-1080-2016
- FDA event ID
- 72961
- Recalling firm
- Value Plastics, Fort Collins, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Dec 2015
- FDA classified
- 9 Mar 2016
- Reported
- 16 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 18 Dec 2015 | Recall initiated by company | |
| 9 Mar 2016 | Classified by FDA | +82 days |
| 16 Mar 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for the parts to crack.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL, 805 West 71st Street, Loveland, CO 80538, packaged in Bags consisting of 100, 500 or 1,000 stopcocks.
Where it was distributed
3 Consignees in NY, PA, MN. No foreign, VA/govt.
Questions about this recall
Is Custom Assembly, Custom Fcffm x/ Tubing Extension recalled?
Yes. Value Plastics recalled Custom Assembly, Custom Fcffm x/ Tubing Extension on 18 Dec 2015. The recall is Class II and its status is Terminated. Recall number Z-1080-2016.
Why was it recalled?
Potential for the parts to crack.
Which lots are affected?
Catalog #: FCA026-001 Lot #s: 67775, 69321, 69814, 70178, 71812, 152127, 152903, 153015
Where was it sold?
3 Consignees in NY, PA, MN. No foreign, VA/govt.
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 21 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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