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Z-1610-2013 Class II Terminated

Recalled by Baxter Healthcare Corp. — Round Lake, IL

FDA device recall Z-1610-2013 was initiated by Baxter Healthcare Corp. on Jun 7, 2013 and is designated Class II. 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. The recall status is terminated (terminated Jun 4, 2014). Affected quantity: 601,230 total.

Recall Details

Product Type: Devices
Report Date: Jul 3, 2013
Initiation Date: Jun 7, 2013
Termination Date: Jun 4, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 601,230 total

Product Description

Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor: Single day Infusor 2 ml/h, Single Day INFUSOR 2 ml/h System, Half Day INFUSOR SV 5 ml/h System, Two Day INFUSOR 2 ml/h System, Two day Infusor 2 ml/h, Multiday Infusor 0.5 ml/h, Multiday INFUSOR 0.5ml/h System, Seven Day Infusor 0.5 ml/h, Seven Day INFUSOR 0.5ml/h System, Basal-Bolus Infusor-15min., Basal/Bolus INFUSOR 0.5 x 2 ml/h System with 15 Minute Lockout, Basal-Bolus Infusor Device Listing: D018045 The Multiday lnfusor. Seven Day lnfusor and the BasaVBolus lnfusor are indicated for patients requiring slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications.

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.

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.

Code Information

Product Codes: 2C1071KJP, 2C1073KJP, 2C1075KJP, 2C1080KJP, 2C1082KJP, 2C1955KJP, 2C1976KJ. Expiration Dates: 06/30/13, 12/31/13, 06/30/14, 12/31/14

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1610-2013
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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