FDA Device recall Z-1609-2013
Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems)
- FDA Device
- Class II
- terminated
- Published 2013-07-03
On 2013-07-03 the FDA classified a Class II recall of Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems) by Baxter Healthcare, citing due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1609-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-07 |
| Published | 2013-07-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device Device Listing: D020871 Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate.
Reason
Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer.
Identifiers
| code_info | Product Code: 2C1073KJP Lot Numbers: 08M002, 08N007, 08N029, 08N030, 08N034, 08N069, 08N070, 09A001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1609-2013%22
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