Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 20, 2020
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Directions for Use for complete loading and operating instructions. Notes: The set should be cha
The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most like…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Bd Switzerland Sarl recalled BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV… - a moderate-severity action.
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV… was recalled by Bd Switzerland Sarl in May 20, 2020. Reason: The products have the potential to leak between the connection of the male luer and the yellow striped tubing…. Check the official notice for the remedy. Verify recall #Z-1969-2020 with the FDA Devices before acting.
The recall
Bd Switzerland Sarl issued this moderate-severity FDA Devices recall-The products have the potential to leak between the connection of the male luer and the yellow striped tubing….
- Moderate
- severity level
- 110K units
- affected scope
- Class II
- classification
- May 20, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1969-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1969-2020) was formally reported on May 20, 2020, with the manufacturer initiating the action on April 9, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Bd Switzerland Sarl is listed as the recalling firm, operating out of Eysins, N/A. Federal records list the affected scope as 110,350, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a … Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide Distribution and the countries of Canada, Belgium.. 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
110,350
Related Recalls
6
3 from same agency
Product description
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Directions for Use for complete loading and operating instructions. Notes: The set should be changed according to facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.
Reason for recall
The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administration set would be inadequate pain control for the patient due to an under-infusion of medication.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1969-2020 |
| Date reported | May 20, 2020 |
| Date initiated | April 9, 2020 |
| Recalling firm | Bd Switzerland Sarl |
| Firm location | Eysins, N/A |
| Affected scope | 110,350 |
| Distribution | Worldwide distribution - US Nationwide Distribution and the countries of Canada, Belgium. |
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-1969-2020) 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? ▼
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Directions for Use for complete loading and operating instructions. Notes: The set should be changed according to facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.. Recalled by Bd Switzerland Sarl. Units affected: 110,350.
Why was this product recalled? ▼
The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administration set would be inadequate pain control for the patient due to an under-infusion of medication.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 20, 2020. Severity: Moderate. Recall number: Z-1969-2020.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide Distribution and the countries of Canada, Belgium..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1969-2020) 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 May 20, 2020. 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.