FDA Device recall Z-2221-2016
Spike Set, 12" Microbore SPM-12
- FDA Device
- Class II
- terminated
- Published 2016-07-27
On 2016-07-27 the FDA classified a Class II recall of Spike Set, 12" Microbore SPM-12 by Walkmed Infusion, citing walkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2221-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-14 |
| Published | 2016-07-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Walkmed Infusion |
| Distribution | US |
Product
Spike Set, 12" Microbore SPM-12. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.
Reason
WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
Identifiers
| code_info | Product Number: 020-204840. Lot Number: 1504031D |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2221-2016%22
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