CLASS II Device recall · Reported 13 Jan 2016 · FDA Enforcement Report
Baxter Clearlink System, Blood Bag Spike Adapter recalled
Baxter Healthcare is recalling Baxter Clearlink System, Blood Bag Spike Adapter, Luer Activated Valve for I.C, distributed nationwide in the US. The recall was initiated on 30 Nov 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-0607-2016
- FDA event ID
- 72787
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Nov 2015
- FDA classified
- 6 Jan 2016
- Reported
- 13 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Other Medical Devices
Timeline
| 30 Nov 2015 | Recall initiated by company | |
| 6 Jan 2016 | Classified by FDA | +37 days |
| 13 Jan 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 dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
Product as listed by the FDA
Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory to transfer a medicinal product from one container to another container.
Where it was distributed
US Nationwide Distribution and the country of Canada
Questions about this recall
Is Baxter Clearlink System, Blood Bag Spike Adapter, Luer Activated Valve for I.C recalled?
Yes. Baxter Healthcare recalled Baxter Clearlink System, Blood Bag Spike Adapter, Luer Activated Valve for I.C on 30 Nov 2015. The recall is Class II and its status is Terminated. Recall number Z-0607-2016.
Why was it recalled?
Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
Which lots are affected?
Lot Numbers: GR323907, GR324806, GR326116, GR326645, GR327528, and GR328534
Where was it sold?
US Nationwide Distribution and the country of 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 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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