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Recall Observatory FDA recall evidence

Device 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.

Z-1609-2013

June 07, 2013

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 65364
Status
Terminated
Classification
Class II
Quantity
601,230 total
Official record key
device-enforcement:Z-1609-2013

Official wording

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.

Code information: Product Code: 2C1073KJP Lot Numbers: 08M002, 08N007, 08N029, 08N030, 08N034, 08N069, 08N070, 09A001

Distribution pattern: Worldwide Distribution - USA (nationwide), Puerto Rico, and Internationally to Brazil, Colombia, Panama, Mexico, Singapore Japan, Australia, New Zealand, Hong Kong, India, Thailand, Taiwan, and Korea.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.