Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 3, 2013
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 Listi
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Baxter Healthcare Corp. recalled Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor: Single d… - a moderate-severity action.
Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor: Single d… was recalled by Baxter Healthcare Corp. in July 3, 2013. Reason: Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhanceme…. Check the official notice for the remedy. Verify recall #Z-1610-2013 with the FDA Devices before acting.
The recall
Baxter Healthcare Corp. issued this moderate-severity FDA Devices recall-Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhanceme….
- Moderate
- severity level
- Class II
- classification
- July 3, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1610-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1610-2013) was formally reported on July 3, 2013, with the manufacturer initiating the action on June 7, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Baxter Healthcare Corp. is listed as the recalling firm, operating out of Round Lake, IL. Federal records list the affected scope as 601,230 total.
The documented reason for this recall is: 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 data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
601,230 total
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1610-2013 |
| Date reported | July 3, 2013 |
| Date initiated | June 7, 2013 |
| Recalling firm | Baxter Healthcare Corp. |
| Firm location | Round Lake, IL |
| Affected scope | 601,230 total |
| Distribution | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1610-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Baxter Healthcare Corp.. Units affected: 601,230 total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 3, 2013. Severity: Moderate. Recall number: Z-1610-2013.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1610-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 3, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.