Brand Name: Coiled Tube Infusors — Class II medical device recall Z-1609-2013
Terminated recall by Baxter Healthcare Corp., reported 2013-07-03, distributed nationwide. Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancemen
| Recall number | Z-1609-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Round Lake, IL, United States |
| Recall initiated | 2013-06-07 |
| Classified | 2013-06-27 |
| Reported by FDA | 2013-07-03 |
| Terminated | 2014-06-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CO, HK, IN, JP, KR, MX, NZ, PA, SG, TH, TW |
| Quantity | 601,230 total |
| Reason classes | packaging |
| Lot numbers | 08M002, 08N007, 08N029, 08N030, 08N034, 08N069, 08N070, 09A001 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1609-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.