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Terminated

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.

FDA Recall Z-1610-2013 · Posted 2013-06-27

Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeFRN
Date Initiated2013-06-07
Date Terminated2014-06-04
Product Quantity601,230 total

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.

Firm Action

Baxter sent an Urgent Produd Recall notification letter dated June 13, 2013, to all affected consignees via USPS. The letter was accompanied by a Customer Reply Form and Affected Product List (table). The letter stated affected products, problem description, risk to health (or health risks), actions to be taken by customers/users and contact information. The recall notification instructs customers to segregate affected product from current inventory and contact Baxter for instructions to return affected product. Customers with questions were instructed to call Baxter at 1-800-437-5176, For questions regarding this recall call 847-270-5556.

Root Cause

Device Design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K884505BASAL/BOLUS INFUSORSBaxter Healthcare Corp · 1989-07-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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